<SUBMISSION>
<ACCESSION-NUMBER>0001299933-05-003560
<TYPE>8-K
<PUBLIC-DOCUMENT-COUNT>2
<PERIOD>20050715
<ITEMS>8.01
<ITEMS>9.01
<FILING-DATE>20050720
<DATE-OF-FILING-DATE-CHANGE>20050719
<FILER>
<COMPANY-DATA>
<CONFORMED-NAME>STAAR SURGICAL CO
<CIK>0000718937
<ASSIGNED-SIC>3851
<IRS-NUMBER>953797439
<STATE-OF-INCORPORATION>DE
<FISCAL-YEAR-END>0101
</COMPANY-DATA>
<FILING-VALUES>
<FORM-TYPE>8-K
<ACT>34
<FILE-NUMBER>000-11634
<FILM-NUMBER>05962661
</FILING-VALUES>
<BUSINESS-ADDRESS>
<STREET1>1911 WALKER AVE
<CITY>MONROVIA
<STATE>CA
<ZIP>91016
<PHONE>6263037902
</BUSINESS-ADDRESS>
<MAIL-ADDRESS>
<STREET1>1911 WALKER AVE
<CITY>MONROVIA
<STATE>CA
<ZIP>91016
</MAIL-ADDRESS>
<FORMER-COMPANY>
<FORMER-CONFORMED-NAME>STAAR SURGICAL COMPANY
<DATE-CHANGED>19920703
</FORMER-COMPANY>
</FILER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>htm_5915.htm
<DESCRIPTION>LIVE FILING
<TEXT>
<!-- CoverPageHeader start -->
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<TITLE> STAAR Surgical Company (Form: 8-K) </TITLE>
</HEAD>
<BODY TEXT="#000000" BGCOLOR="#FFFFFF" ALINK="#0000FF" HLINK="#FF0000" VLINK="#800080">
<A NAME="DOCUMENT_TOP">&nbsp;</A>
<P>
<!-- CoverPageHeader end --><!-- CoverPageTitle START -->
<A NAME="DOCUMENT_TOP">&nbsp;</A>
<HR NOSHADE>
<P>
<P ALIGN="CENTER">
<FONT SIZE="4">
		UNITED STATES<BR>
	SECURITIES AND EXCHANGE COMMISSION
</FONT>
<BR>
<FONT SIZE="2">
	WASHINGTON, D.C. 20549
</FONT>
<P ALIGN="CENTER">
<FONT SIZE="5">
	FORM 8-K
</FONT>
<FONT SIZE="2">

</FONT>
</P>
<P ALIGN="CENTER">
<FONT SIZE="3">
	CURRENT REPORT
</FONT>
</P>
<P ALIGN="CENTER">
<FONT SIZE="2">
	Pursuant to Section&nbsp;13 or 15(d) of the Securities Exchange Act of 1934
</FONT>
</P>
<CENTER>
<TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%">
<TR VALIGN="BOTTOM">
<TD WIDTH="51%">
	&nbsp;
</TD>
<TD WIDTH="5%">
	&nbsp;
</TD>
<TD WIDTH="44%">
	&nbsp;
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	Date of Report (Date of Earliest Event Reported):
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	July 15, 2005
</FONT>
</TD>
</TR>
</TABLE>
<BR>
</CENTER>
<!-- CoverPageTitle END --><!-- CoverPageRegistrant START -->
<P ALIGN="CENTER"><!-- -->
<FONT SIZE="6">
	STAAR Surgical Company
</FONT>
<FONT SIZE="2">
<BR>__________________________________________<BR>
	(Exact name of registrant as specified in its charter)
</FONT>
<CENTER>
<TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%">
<TR VALIGN="BOTTOM">
<TD WIDTH="33%">
	&nbsp;
</TD>
<TD WIDTH="34%">
	&nbsp;
</TD>
<TD WIDTH="33%">
	&nbsp;
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	Delaware
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	0-11634
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	95-3797439
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
_____________________<BR>
	(State or other jurisdiction
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
_____________<BR>
	(Commission
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
______________<BR>
	(I.R.S. Employer
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	of incorporation)
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	File Number)
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	Identification No.)
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	1911 Walker Ave, Monrovia, California
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	91016
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
_________________________________<BR>
	(Address of principal executive offices)
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
___________<BR>
	(Zip Code)
</FONT>
</TD>
</TR>
</TABLE>
</CENTER>
<CENTER>
<TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%">

<TR VALIGN="BOTTOM">
<TD WIDTH="51%">
	&nbsp;
</TD>
<TD WIDTH="5%">
	&nbsp;
</TD>
<TD WIDTH="44%">
	&nbsp;
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	Registrant&#146;s telephone number, including area code:
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="CENTER" VALIGN="TOP">
<FONT SIZE="2">
	626-303-7902
</FONT>
</TD>
</TR>
</TABLE>
</CENTER>
<P ALIGN="CENTER">
<FONT SIZE="2">
	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
</FONT>
<P ALIGN="CENTER">
<FONT SIZE="2">
	&nbsp;
</FONT>
<!-- CoverPageRegistrant END --><P><FONT SIZE="2">
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:</FONT>
</P>
<P><FONT SIZE="2">
[&nbsp;&nbsp;]&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<br>
</P></FONT><!-- PageBreak START -->
<P>
<HR NOSHADE>
<DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS">
<A HREF="#DOCUMENT_TOP">
<U>
<B>
<FONT SIZE="2">Top of the Form</FONT>
</B>
</U>
</A>
</DIV>
<!-- PageBreak END --><!-- Item START -->
<P ALIGN="LEFT">
<FONT SIZE="2">
<B>
	Item 8.01 Other Events.
</B>
</FONT>
</P>
<P ALIGN="LEFT">
<FONT SIZE="2">
As a manufacturer of medical devices, STAAR Surgical Company&#x2019;s manufacturing processes and facilities are subject to regulation by the U.S. Food and Drug Administration (the "FDA").  The FDA inspects STAAR&#x2019;s facilities from time to time to determine whether we are in compliance with quality system regulations relating to such things as manufacturing practices, validation, testing, quality control and product labeling, and in compliance with FDA medical device reporting obligations. <br><br>On July 5, 2005 STAAR received a letter from the FDA (the "FDA Letter") relating to a List of Inspectional Observations ("Form 483"), which the FDA had delivered to STAAR on September 23, 2004 at the conclusion of the FDA&#x2019;s most recent inspection of STAAR.  The FDA Letter referred to STAAR&#x2019;s letter responding to the Form 483 observations (the "November 2004 Response"), which STAAR had delivered to the FDA on November 4, 2004 and updated by letter on February 11, 2005. <br> <br>The FDA Letter requested that STAAR provide additional information related to the Form 483 observations, and presented the FDA&#x2019;s conclusion that based on STAAR&#x2019;s earlier responses STAAR had "failed to adequately correct numerous violations" noted in the Form 483.  The FDA Letter gave STAAR ten calendar days from its receipt of the letter to provide responses and supporting documentation.  The letter covers 14 of the 36 original Form 483 observations, and requests specific information on 27 of the 84 original sub-observations in the Form 483.  A copy of the FDA Letter is attached to this report as Exhibit 99.1 and is incorporated herein by this reference.<br><br>On July 15, 2005 STAAR provided its response to the FDA by letter (the "Response Letter") within the ten-calendar-day deadline.  The Response Letter, together with 120 exhibits, comprised 15 volumes and provided a substantive and detailed response on each of the 27 sub-observations.  The responses included requested documentation, updates on corrective actions taken by STAAR following the inspection that ended in September 2004 and following STAAR&#x2019;s November 2004 Response, and information gathered after those dates.  On three points where the FDA disagreed with STAAR&#x2019;s interpretation of the FDA regulations, STAAR provided information showing compliance with the regulations under the FDA&#x2019;s interpretation or corrective actions undertaken to achieve compliance in accordance with the perspective provided by the FDA. <br> <br>STAAR also responded to the concerns expressed in Footnote 1 of the FDA Letter, where the FDA suggested that STAAR "conduct a thorough review of your records, processes, and operations to determine whether you are in compliance with the Act and applicable FDA regulations" and requesting that STAAR "immediately correct all of your violations."  In response to this concern, STAAR described the comprehensive review of its quality system undertaken following receipt of the FDA&#x2019;s Warning Letters dated December 22, 2003 and April 23, 2004.  Since that time, with the assistance of Quintiles Consulting, STAAR developed a comprehensive Global Quality Systems Action Plan ("QSAP").  The QSAP was completed in April 2004, and the initial version was provided to the FDA on May 14, 2004.<br>  <br>STAAR described to the FDA the significant resources devoted to implementing the QSAP and STAAR&#x2019;s continuous updating of the QSAP to incorporate feedback from both internal and external sources.  This has included addressing the issues identified in the FDA&#x2019;s Form 483 observations and additional evaluations and observations made by KEMA Registered Quality, Inc. and consultants at King & Spalding LLP.  STAAR provided a current copy of the revised QSAP along with the Response Letter.  <br><br>STAAR cannot predict the timing or substance of the FDA&#x2019;s reaction to the Response Letter.  The FDA may elect to re-audit STAAR&#x2019;s quality systems and medical device reporting systems before giving a definitive response.  However, STAAR can give no assurance that the FDA will not respond more rapidly.  <br><br>STAAR believes that the FDA will pursue enforcement action against STAAR if it finds the information provided in the Response Letter to be inadequate.  FDA enforcement action, if taken, would most likely have a material and adverse impact on STAAR and its prospects, and can include seizure of products or an injunction requiring STAAR to suspend some or all of its U.S. distribution for a period of six months or more.  <br><br>STAAR believes that the FDA is unlikely to approve marketing of the VISIAN&#174; ICL in the U.S. while enforcement or other similar proceedings are pending.  In part, this is because STAAR must be deemed compliant with the FDA&#x2019;s Quality System Regulations and Medical Device Reporting Regulations before final marketing approval of the VISIAN ICL will be authorized. <br><br>All statements in this report that are not statements of historical fact are forward-looking statements, including statements about  actions that may be taken by the FDA, and any other statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of new products, services or developments, statements of belief and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements.  The risks and uncertainties include the outcome of our proceedings with the FDA Office of Compliance, including our response to the letter received from the FDA on July 5, 2005, our ability to implement our cost savings strategies and realize our expected savings, our limited capital resources, the success of our efforts in realigning our management team, our ability to reverse the decline in domestic sales of IOLs, our ability to maintain or enhance our existing product sales and gross profit margin and reduce compliance expenditures, the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, access to financing and other factors beyond the control of STAAR Surgical Company, including those detailed from time to time in STAAR Surgical Company&#x2019;s reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.<br>
</FONT>
</P>
<!-- Item END -->
<BR><BR><BR><BR><!-- Item START -->
<P ALIGN="LEFT">
<FONT SIZE="2">
<B>
	Item 9.01 Financial Statements and Exhibits.
</B>
</FONT>
</P>
<P ALIGN="LEFT">
<FONT SIZE="2">
Exhibit 99.1  Letter from U.S. Food and Drug Administration dated June 30, 2005.
</FONT>
</P>
<!-- Item END -->
<BR><BR><BR><BR><P ALIGN="LEFT" STYLE="FONT-SIZE: 10PT"></P><!-- PageBreak START -->
<P>
<HR NOSHADE>
<DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS">
<A HREF="#DOCUMENT_TOP">
<U>
<B>
<FONT SIZE="2">Top of the Form</FONT>
</B>
</U>
</A>
</DIV>
<!-- PageBreak END --><!-- SignatureHeader START -->
<P ALIGN="CENTER">
<FONT SIZE="2">
<B>
	SIGNATURES
</B>
</FONT>
</P>
<P ALIGN="LEFT">
<FONT SIZE="2">
	Pursuant to the requirements of the Securities Exchange Act of 1934, the
	registrant has duly caused this report to be signed on its behalf by the
	undersigned hereunto duly authorized.
</FONT>
</P>
<!-- SignatureHeader END --><!-- Signature START -->
<CENTER>
<TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%">
<TR VALIGN="BOTTOM">
<TD WIDTH="19%">
	&nbsp;
</TD>
<TD WIDTH="34%">
	&nbsp;
</TD>
<TD WIDTH="3%">
	&nbsp;
</TD>
<TD WIDTH="1%">
	&nbsp;
</TD>
<TD WIDTH="43%">
	&nbsp;
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD COLSPAN="3" VALIGN="TOP" ALIGN="LEFT">
<FONT SIZE="2">
	STAAR Surgical Company
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD VALIGN="TOP">
<FONT SIZE="2">
<I>
	July 19, 2005
</I>
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	By:
</I>
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	/s/ David Bailey
</I>
<BR>
</FONT>
</TD>
</TR>
<TR>
<TD VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<HR SIZE="1" NOSHADE>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	Name: David Bailey
</I>
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	Title: Chief Executive Officer
</I>
</FONT>
</TD>
</TR>
</TABLE>
</CENTER>
<!-- Signature END --><!-- PageBreak START -->
<P>
<HR NOSHADE>
<DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS">
<A HREF="#DOCUMENT_TOP">
<U>
<B>
<FONT SIZE="2">Top of the Form</FONT>
</B>
</U>
</A>
</DIV>
<!-- PageBreak END --><P ALIGN="CENTER">
<FONT SIZE="2">
	Exhibit&nbsp;Index
</FONT>
<CENTER>
<TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="60%">
<TR VALIGN="BOTTOM">
<TD WIDTH="8%">
	&nbsp;
</TD>
<TD WIDTH="15%">
	&nbsp;
</TD>
<TD WIDTH="77%">
	&nbsp;
</TD>
</TR>

<BR>
<TR VALIGN="BOTTOM">
<TD NOWRAP ALIGN="LEFT">
<FONT SIZE="1">
<B>
	Exhibit No.
</B>
</FONT>
</TD>
<TD>
<FONT SIZE="1">
	&nbsp;
</FONT>
</TD>
<TD NOWRAP ALIGN="LEFT">
<FONT SIZE="1">
<B>
	Description
</B>
</FONT>
</TD>
</TR>
<TR VALIGN="BOTTOM">
<TD NOWRAP ALIGN="CENTER">
<HR SIZE="1" NOSHADE>
</TD>
<TD>
<FONT SIZE="1">
	&nbsp;
</FONT>
</TD>
<TD NOWRAP ALIGN="CENTER">
<HR ALIGN="LEFT" SIZE="1" WIDTH="88%" NOSHADE>
</TD>
</TR>





<TR VALIGN="BOTTOM">
<TD VALIGN="TOP" WIDTH="8%" nowrap>
<FONT SIZE="2">
<DIV ALIGN="LEFT">
	99.1
</DIV>
</FONT>
</TD>
<TD WIDTH="15%">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD ALIGN="LEFT" VALIGN="TOP" WIDTH="77%">
<FONT SIZE="2">
Letter from U.S. Food and Drug Administration dated June 30, 2005.
</FONT>
</TD>
</TR></TABLE></CENTER><!-- HTMLFooter START -->
</BODY>
</HTML>
<!-- HTMLFooter END -->
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<TITLE> EX-99.1 </TITLE>
</HEAD>
<BODY TEXT="#000000" BGCOLOR="#FFFFFF" ALINK="#0000FF" HLINK="#FF0000" VLINK="#800080">

<BODY style="font-family: 'Times New Roman',Times,serif">


<P align="left" style="font-size: 10pt"><FONT style="font-size: 12pt">DEPARTMENT OF HEALTH &#038; HUMAN SERVICES Public Health Service
</FONT>

<P align="right" style="font-size: 12pt">Food and Drug Administration<BR>
Los Angeles District<BR>
19701 Fairchild<BR>
Irvine, California 92612-2506<BR>
Telephone (949)&nbsp;608-2900



<P align="left" style="font-size: 12pt"><U>CERTIFIED MAIL</U>
<BR>
<U>Return-Receipt Requested</U>


<P align="left" style="font-size: 12pt">June&nbsp;30, 2005


<P align="left" style="font-size: 12pt">Mr.&nbsp;David Bailey
<BR>
President and CEO
<BR>
Staar Surgical Company
<BR>
1911 Walker Avenue
<BR>
Monrovia, CA 91016


<P align="left" style="font-size: 12pt">Dear Mr.&nbsp;Bailey:


<P align="left" style="font-size: 12pt">Between July&nbsp;28 and September&nbsp;23, 2004, the Food and Drug Administration (&#147;FDA&#148;) conducted its most
recent inspection of Staar Surgical Company&#146;s Monrovia, California facility (hereafter, &#147;Staar&#148; or
&#147;you&#148;). During this inspection, FDA investigators observed numerous violations of the Quality
System (&#147;QS&#148;) regulations, 21 C.F.R. Part&nbsp;820, and the Medical Device Reporting (&#147;MDR&#148;)
regulations, 21 C.F.R. Part&nbsp;803, and documented these violations on a List of Inspectional
Observations (&#147;Form&nbsp;483&#148;). At the conclusion of this inspection, FDA investigators gave your firm
a copy of the Form&nbsp;483. By letters dated November&nbsp;4, 2004, and February&nbsp;11, 2005, you responded to
the Form&nbsp;483 (hereafter, respectively, &#147;November&nbsp;2004 response&#148; and &#147;February&nbsp;2005 response&#148;).


<P align="left" style="font-size: 12pt">Your responses reveal that Staar has failed to adequately correct numerous violations that FDA
investigators documented on the Form&nbsp;483. These violations cause your medical devices to be
adulterated and misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (&#147;the
Act&#148;).


<P align="left" style="font-size: 12pt">FDA is gravely concerned about Staar&#146;s serious, continuing violations and is prepared to seek the
appropriate remedies under the Act. This letter is FDA&#146;s final attempt to notify you of your
non-compliance. It addresses the violations noted in the Form&nbsp;483 that you still have not
corrected and briefly explains why your responses to these violations have been inadequate.
<sup>1</sup> FDA requests that, within ten (10)&nbsp;calendar days of receipt of this letter, you
provide FDA with a response to each violation listed in this letter, as well as any and all
documentation supporting your position.
<BR>


<P align="center" style="font-size: 10pt; display: none">1
<!-- PAGEBREAK -->



<P align="left" style="font-size: 12pt">The following items are the violations of the QS and MDR regulations at Staar that are
currently known to FDA:


<P align="left" style="font-size: 12pt"><U><B>QS Regulations</B></U>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">I.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to validate a process that cannot be fully verified by subsequent inspection
and test, and failed to ensure that such process is validated with a high degree of assurance
and approved according to established procedures, in violation of <B>21 C.F.R. &#167; 820.75(a)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have never fully characterized the Collamer IOL and the ICL under
clinical study to quantify the amount of impurities and other indicators of incomplete
polymerization. HEMA and other components, such as inhibitors and impurities, are
potentially toxic to the eye and considered allergens. You performed a toxicological
review on May&nbsp;18, 2004, to determine a safe concentration of unreacted HEMA in lenses
but did not identify or analyze the safe concentration of unknown impurities
characteristic of the lens material. Peaks found during a GC analysis were not
quantified or characterized during your toxicological review. <U>See</U> Form&nbsp;483,
Item l(e).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;4, 2004 response to this observation is inadequate. Your response states that HEMA
is not an allergen and is not toxic. However, you failed to provide any evidence to support this
statement. Additionally, your firm references ISO 11979-6 Annex B, which requires manufacturers to
justify and document the use of solvents used in the extraction medium and to evaluate the most
appropriate solvent to determine which is best for achieving the appropriate level of extraction.
Please provide documentation indicating whether you have complied with ISO 11979-6 Annex B, as well
as evidence that HEMA is not toxic or an allergen.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>As of July&nbsp;28, 2004, you have not validated the MSI-TF and MSI-PF IOL
injectors to substantiate the reusable claim on each product&#146;s label. Your firm
labels the MSI-PF/TF injectors as reusable devices and recommends resterilizing the
devices using a steam or moist heat sterilization method. However, you have no
validation process to prove that the devices can be re-sterilized and that the
materials can withstand the re-sterilization process. <U>See</U> Form&nbsp;483, Item
l(g).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that you will validate the injector for multiple
uses to support the reusable claim. You also provided a corrective action number, IACA M04-20,
which tracks the progress of completion of this validation. Your February&nbsp;2005 response indicates
that this validation was to be completed by March&nbsp;31, 2005. Therefore, FDA requests that you
please provide it with the status of this validation, including all supporting documentation
referenced in the February&nbsp;2005 response.


<P align="left" style="font-size: 12pt"><FONT style="font-size: 12pt"><sup>1</sup>Please be aware that other violations of the Act
and FDA regulations may exist at your facility of which FDA is currently
unaware. Furthermore, the omission of a Form&nbsp;483 item from this letter does
not necessarily mean that you have corrected that item. Therefore, FDA
suggests that you conduct a thorough review of your records, processes, and
operations to determine whether you are in compliance with the Act and
applicable FDA regulations, and it requests that you immediately correct all of
your violations.
</FONT>

<P align="center" style="font-size: 10pt; display: none">2
<!-- PAGEBREAK -->

<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">C.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Validation report D04-009-R, &#147;Tooling Qualification for MSI Injector Cones
PIN 35-0214-50 Rev G and PIN 35-0209-50 Rev H,&#148; is inadequate. This validation
report, which you conducted as a result of the cracking and failure of the distal end
of the nose cone, was inadequate because you used 30 samples from one pilot batch of
500 short nose cones, PIN 35-0214-50 Rev. G. The procedure for &#147;Process and Software
Validation and Equipment Qualification&#148; (&#147;QSSOP 2006&#148;) requires the results of three
production runs or pilot batches to demonstrate repeatability and reproducibility.
The result of just one production run of 30 samples used in the validation study
cannot demonstrate repeatability and reproducibility. <U>See</U> Form&nbsp;483, Item
l(h).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your February&nbsp;2005 response indicates that you have completed your revisions of
QSSOP 2006. However, FDA cannot verify the adequacy of this action unless and
until it reviews your revised version of QSSOP 2006.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">D.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have not fully validated the ejection force testing specifications for
your lenses, injectors, and cartridges, as required by your procedures for &#147;Design
Control&#148; (&#147;QSSOP 2005&#148;) and QSSOP 2006. Specifically, you have no written validation
protocol and report to determine ejection force specifications. Moreover, prior to
the validation of ejection force testing of MTC-60 and SFC-25 cartridges in November
and December of 2003, you failed to pre-determine the test method, numbers of product
lots and samples used in the study, and acceptance criteria. <U>See</U> Form&nbsp;483,
Item&nbsp;1(i).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that you will revise QSSOP 2005 and QSSOP 2006 to
link &#147;Test Method Verification and Validation&#148; (&#147;QSSOP 2021 &#147;) to these respective procedures.
Your February&nbsp;2005 response states that the target completion date was March&nbsp;18, 2005. Therefore,
please provide FDA with the status of your corrective action and revised SOPs.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">II.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to document validation activities and results when computers or automated
data processing systems are used as part of production or the quality system, in violation of
<B>21 CFR 820.70(i)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The user requirements for error handling and security were not defined in the
validations of the following off-the-shelf software: (1)&nbsp;the Nexygen force testing
software program, which is used in the ejection force testing of lenses, injectors,
and cartridges; and (2)&nbsp;the Excel software program, which is used to determine the
cycle time for the irradiation polymerization of Collamer. The validations of these
software programs do not include the elements for error handling, security, and backup
to ensure data integrity.</TD>
</TR>



</TABLE>

<P align="center" style="font-size: 10pt; display: none">3
<!-- PAGEBREAK -->


<P><TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 12pt">



</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response states that you did not completely address all of the requirements for
validating off-the-shelf software and that you will write a new Software Validation SOP. Your
February&nbsp;2005 response indicates that a second draft of this SOP was reviewed on February&nbsp;7, 2005.
Please provide FDA with the present status of this SOP and a copy of the most current draft.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">III.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish and maintain acceptance procedures to ensure that specified
requirements for in-process product are met, in violation of <B>21 CFR 820.80(c)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The hardness testing of Collamer buttons, described in the procedure for
&#147;Collamer Raw Material Sample Preparations and Testing&#148; (&#147;QSSOP 1045&#148;), is deficient
because the procedure requires the arithmetic mean to be calculated by only one
measurement from the center of five different test specimens. However, ASTM Standard
D2240 requires five measurements, each at different positions, that are at least 6.0
mm apart on the specimen. <U>See</U> Form&nbsp;483, Item&nbsp;29(c).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that your procedure requires measurement at the
center of five separate samples, cut from one to two rods from the same Collamer batch. If this is
your procedure, validation is needed to justify it.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">IV.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish and maintain procedures for investigating the cause of
non-conformities relating to product, processes, and the quality system, in violation of <B>21
CFR 820.</B><B>100(a)(2)</B><B>.</B></TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You implemented CAPA M03-54 to determine the Root Cause Analysis of
complaints involving refractive change and refractive surprise with the Collamer IOL.
Validation Study V02-036 and Technical Report 99-1008 are cited to document the fact
that the lens is not affected by production or storage. However, the reports indicate
that the lens fails stability after accelerated and long-term storage such that the
power of the lens falls out of specification. <U>See</U> Form&nbsp;483, Item&nbsp;4(a).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item claims that the root cause analysis
performed under CAPA M03-54 was &#147;robust and accurate&#148; with regard to conclusions
drawn for refractive surprise and refractive change over time. However, you did
not include a copy of CAPA M03-54 or the referenced validation studies in your
response. Furthermore, validation study V02-036 shows that lens power or diopter
changed over time, and the lenses had to be re-hydrated in new BSS for 48 hours in
order to meet the established acceptance criteria for diopter. You changed your
protocol for this test to receive a passing result. This change was not validated
prior to product release. Rehydration was not specified in the Directions For Use.
Please provide these validation studies and label changes to FDA for review.


<P align="center" style="font-size: 10pt; display: none">4
<!-- PAGEBREAK -->

<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>CAPA M03-65 and NCI M03-05 were implemented to determine the root cause of
posterior capsule tears with the Collamer IOL. The analysis defines two causes of
this event: Surgeon Technique/Design or patient related issues. The analysis briefly
states that the design of the lens could not be an issue because it does not have a
hard surface. No other design or material related issues were addressed in this
analysis. <U>See</U> Form&nbsp;483, Item&nbsp;4(c).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response provides a fault-tree analysis that includes design
issues pertaining to the plunger head. Despite your identification of the lens
design and lens material as possible causes of lens and capsule tears, these were
not evaluated. This is a separate issue that needs a study for a complete root
cause analysis. For all MDRs and unreported complaints of this nature, you must
investigate and document both the lens and the delivery system.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">V.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to verify and validate the corrective and preventive action to ensure that
such action is effective and does not adversely affect the finished device, in violation of <B>21
CFR 820.</B><B>100(a)(4)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>CAPA M03-l4 and IACA M03-02 were opened to address the existence of
incomplete training records and to train all personnel in revised and new SOPs. The
CAPA was closed on October&nbsp;10, 2003, but your training records are incomplete for the
firm&#146;s Chief Chemist and Director of Manufacturing. <U>See</U> Form&nbsp;483, Item&nbsp;4(e).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response states that the cited CAPAs have no relationship to the
training of the Chief Chemist or the Director of Manufacturing. However, since
your firm&#146;s Director of Manufacturing and the Chief Chemist are intimately involved
in the Collamer manufacturing process, as shown by their signatures and initials on
reports and procedures, FDA regulations require that you train these individuals.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>CAPA M04-07 and IACA M04-02 added two new medical reviewers to the complaint
review process. The CAPA addressed training of the Complaint Department staff but not
the medical reviewers. As of the date of this letter, you have not shown that you
have provided any training to the medical reviewers. <U>See</U> Form&nbsp;483, Item&nbsp;4(f).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response states that one of your contracted medical reviewers had no
responsibility for making MDR decisions and was not required to be trained in Staar complaint
handling procedures. This outside contractor, however, was defined as a medical reviewer and
evaluated complaints for your firm. Your contractor contacted complainants and provided an opinion
upon which your firm based its conclusions to close cases and/or file MDRs. The contractor&#146;s
opinion does not seem to be based on


<P align="center" style="font-size: 10pt; display: none">5
<!-- PAGEBREAK -->

<P align="left" style="font-size: 12pt">knowledge of the QS and MDR regulations. This may have contributed to your firm not reporting
adverse events to FDA. All personnel responsible for reviewing and evaluating complaints must be
trained in Staar&#146;s complaint handling procedures.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">VI.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to analyze processes, work operations, concessions, quality audit reports,
quality records, service records, complaints, returned product, and other sources of quality
data to identify existing and potential causes of nonconforming product, or other quality
problems, in violation of <B>21 CFR 820.</B><B>100(a)(1)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>CAPA M03-27, M03-64, and M04-29 are in response to complaints regarding
blurred vision, cloudy vision, and YAG procedures associated with secondary surgical
interventions. The CAPAs have been closed and state that you will continue to monitor
these complaints and trends. However, you changed your complaint coding system.
Therefore, codes no longer exist for these event types, and the information is not
captured in your database for analysis and investigation. <U>See</U> Form&nbsp;483, Item
4(b).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response states that there are inaccuracies in FDA&#146;s observation.
<BR>
Specifically, you state that CAPA M03-27 is currently open to capture the retrospective
investigation of all complaints received by your firm from January&nbsp;1, 2001, to December&nbsp;31, 2003,
per agreement between Staar and OSB/FDA. FDA disagrees with your response. You are still not
adequately investigating and analyzing current complaints that relate to blurred vision, cloudy
vision, and secondary YAG. Moreover, your coding system is not specific to each event type.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">VII.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish and maintain procedures for receiving, reviewing, and evaluating
complaints by a formally designated unit, in violation of <B>21 CFR 820.198(a)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You are not obtaining all information relevant to the complaint, including
the lot number and type of device. Twenty out of twenty complaints reviewed by the
FDA investigators were missing information related to the device. For instance,
complaint 401056 reported hyperopic shift in patients with the Collamer lens, and
complaint 401237 reported that the Foam Tip Plunger was not advancing properly through
the cartridge and injector. The only information you recorded in each of these
complaints was the lot number of the cartridge; you did not obtain information
regarding the serial number or lot number of the lens involved in each complaint.
After concluding that the plunger caused the event, the complaint was closed.
However, no information regarding this device was recorded in your complaint database.
<U>See</U> Form&nbsp;483, Item&nbsp;14.</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response claims that information is missing from the complaints
because it was not provided to you when the complaint was reported. This is
unacceptable. Any complaint involving the possible failure of a device to meet its
specifications must be reviewed, evaluated,


<P align="center" style="font-size: 10pt; display: none">6
<!-- PAGEBREAK -->


<P align="left" style="margin-left:16%; font-size: 12pt">and investigated. <U>See</U> 21 C.F.R. &#167; 820.198(c). Without having all the
information pertaining to a failed device, you cannot perform a proper complaint
evaluation.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">VIII.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to process all complaints in a uniform and timely manner, in violation of <B>21
CFR 820.</B><B>198(a)</B><B>(I)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have not documented all of the devices involved in an adverse event,
including the IOLs, cartridges, injectors, and type of lubricant. For instance, if an
IOL had become stuck in a cartridge, you documented only the IOL or cartridge in the
complaint report form, instead of both, even though both devices had been returned for
evaluation. <U>See</U> Form&nbsp;483, Item&nbsp;12(a).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response claims that the complaints are not associated with
adverse events as the observation reads. However, even if these complaints are not
associated with adverse events, they are associated with device malfunctions, and
device malfunctions must be captured and documented in the complaint database.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your firm&#146;s complaint procedure (&#147;QSSOP 2009&#148;) requires a Quality Engineer
(&#147;QE&#148;) to review files prior to MDR reporting. There is no system in place to ensure
files are reviewed and returned in a timely manner. For instance, complaint 400183
was received February&nbsp;26, 2004, and additional clinical information was provided to
your firm on March&nbsp;29, 2004. The QE evaluation was completed on April&nbsp;3, 2004, but
was not returned to Staar&#146;s complaint department until June&nbsp;16, 2004. The
supplemental MDR report was not submitted to the FDA until June&nbsp;14, 2004. <U>See</U>
Form&nbsp;483, Item&nbsp;12(b).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states that you are revising QSSOP 2009 to
include targets for timely review of files and processing. However, your firm has
not provided FDA with the expected date of completion or a draft of this revision.
Please provide this information to FDA.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">VIV.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to review and evaluate all complaints to determine whether an investigation
is necessary, in violation of <B>21 CFR 820.198(b)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your firm is recoding injector/cartridge failures and malfunctions as if they
happened prior to delivery into the eye, and thus, you are not tracking and using
these failures and malfunctions in Staar&#146;s trend analysis or root-cause
investigations. As a result, you are downgrading your complaints to a non-complaint
status. Specifically, complaints 401170 and 401066 were recoded as 7 A, &#147;No longer a
complaint, &#147; and the information related to these complaints are not captured in your
firm&#146;s database for trending or</TD>
</TR>


</TABLE>

<P align="center" style="font-size: 10pt; display: none">7
<!-- PAGEBREAK -->


<P><TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 12pt">



</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">failure mode analysis. <U>See</U> Form&nbsp;483, Item&nbsp;13(b).



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item provides a traceability table for the
changes made in your complaint coding system. This table is used to track the
coding changes made. Although you provided a summary of the coding changes, you
have not shown how the codes changed from 2002 to 2004. Please provide this
information to FDA.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your firm is not evaluating complaints involving capsule tears where the
patient is noted as having a pre-existing condition such as weak zonules. The
complaints are recoded such that the information is no longer retained in your
complaint database. <U>See</U> Form&nbsp;483, Item&nbsp;13(c).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states that all complaints involving
capsule tears are evaluated whether or not any pre-existing condition exists.
While the narrative information may be retained, it is the coded information that
is used for trending, tracking, and evaluation. Therefore, please provide FDA with
documentation explaining the coding changes, as well as how these complaints have
been tracked, trended, and evaluated.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">C.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Complaints received from foreign users of your devices are maintained outside
of the United States at your Switzerland facility. These files were not available for
review. <U>See</U> Form&nbsp;483, Item&nbsp;15.</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">During the inspection you provided FDA a summary spreadsheet of the foreign complaints. However,
without copies of the foreign complaint files, there is no way to be sure whether this summary is
representative of the information captured in the actual complaint files.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">X.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to address incomplete design input requirements, in violation of <B>21 C.F.R. &#167;
820.30(c)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Specifically, there was no written justification in the design history file
(&#147;DHF&#148;), for the Elastimide three-piece Collamer Intraocular lens, model CQ2003V, when
the design output did not meet the input requirements. For example, the input
requirement for diopter range was 10.5 &#151; 34 (in 0.5 Diopter Increments), but the
approved output was only up to 25.0. <U>See</U> Form&nbsp;483, Item&nbsp;26(c).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">When our investigator brought this to your attention, he was told that the diopter range was
changed due to machine limitations at Monrovia. However, you did not document in the DHF the
reason and approval for the change. Your November&nbsp;2004 response agrees that the original design
input document was not updated to reflect a phased release for the CQ2003V lens. Your response
refers to a memo written to the DHF to explain the phase approach that was taken. However, you did
not provide a copy of the memo or provide


<P align="center" style="font-size: 10pt; display: none">8
<!-- PAGEBREAK -->

<P align="left" style="font-size: 12pt">the explanation to FDA. Please provide this information to FDA.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">XI.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish and maintain a DHF for each type of device that contains or
references the records necessary to demonstrate that the design was developed in accordance
with the approved design plan and the requirements, in violation of 21 CFR 820.300).</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Staar could not locate the DHF for Collamer lens CC4204BF despite repeated
requests for this information by FDA investigators during the inspection. You
provided a file to the FDA on September&nbsp;9, 2004, but it contained information FDA
previously viewed in the PMA for this device. <U>See</U> Form&nbsp;483, Item&nbsp;34.</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item provided a DHF index, which is a retrospective summary for
product developed prior to 1996. However, you have not provided copies of the actual information
contained in the DHF for Collamer lens CC4204BF. Please provide this information to FDA.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">XII.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to maintain device history records that include the primary identification
label and labeling used for each production unit, in violation of <B>21 CFR 820.184(e)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The device history record for each lot of injector, cartridge, and each IOL
does not include the primary identification label and labeling. <U>See</U> Form&nbsp;483,
Item&nbsp;35.</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states that you will modify the DHR
documentation to include a hard copy of the label and that the corrective action
IACA M04-16 was opened to track the progress. Your February&nbsp;2005 status report
indicates a target completion date of February&nbsp;28, 2005. Please provide FDA with
documentation of your progress on this item.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">XIII.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish and maintain procedures to control all QS documents, in
violation of <B>21 CFR 820.40</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The SOPs &#147;Document Control&#148; (&#147;QSSOP 2000, Rev D&#148;) and &#147;Quality System
Document Change Control&#148; (&#147;QSSOP 2001-1&#148;) do not describe the use of Form&nbsp;STE004/K for
formatting part numbers. <U>See</U> Form&nbsp;483, Item&nbsp;32(a).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that you will update your SOPs to reflect the use
of form STE004/K. The February&nbsp;2005 status report indicates a targeted completion date of February
28, 2005. Please provide the status of your corrections for this item and any supporting
documents.


<P align="center" style="font-size: 10pt; display: none">9
<!-- PAGEBREAK -->

<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>The procedures for QSSOP 2000, Rev D and QSSOP 2001-1 lack a system to
obsolete inactive part numbers. <U>See</U> Form&nbsp;483, Item&nbsp;32(b).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that QSSOP 2000-1 section 5.1.1 includes the
process for obsoletting inactive part numbers. However, FDA has observed that QSSOP 2000-1 section
5.1.1 does not specifically address the system/process for making inactive part numbers obsolete.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">XIV.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to establish procedures for identifying training needs and ensure that all
personnel are trained to adequately perform their assigned responsibilities, in violation of
<B>21 CFR 820.25(b)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your Director of Manufacturing and Chief Chemist, who are responsible for
manufacturing Collamer rods for the firm&#146;s IOLs and ICLs, have not been trained in
your quality procedures and in the new SOP, &#147;Radiation Polymerization of Collamer&#148;
(&#147;MSOP 1009, Rev. C&#148;), dated August&nbsp;10, 2004. The last recorded training for the
Director of Manufacturing is dated April&nbsp;25, 2001. The last recorded training for the
Chief Chemist is September&nbsp;15, 2000. <U>See</U> Form&nbsp;483, Item&nbsp;9(a).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states the responsibilities of these
persons as senior managers, including review and approval of all Collamer
manufacture and quality control procedures, obviates the need for formal training
records in these specific procedures. This is not correct. These persons must be
trained in all applicable manufacturing and production related procedures.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>An outside physician was contracted as one of your Medical Reviewers for
complaints. As a Medical Reviewer, this physician determines whether an adverse event
occurred for MDR reporting purposes. This physician, however, has not been trained in
your Complaint Handling or MDR procedures. <U>See</U> Form&nbsp;483, Item&nbsp;9(b).</TD>
</TR>

</TABLE>


<P align="left" style="font-size: 12pt">Your November&nbsp;2004 response to this item states that this Medical Reviewer was to evaluate the
clinical/patient aspects of the alleged complaints, not to determine MDR reportability. However,
your complaint handling procedure states that the Medical Reviewer is contacted during the
investigation of complaints that involve patient issues to determine whether there is an issue as
to the safety or efficacy of a Staar device. It also states that the Medical Reviewer will
immediately initiate a CAPA report. Moreover, the Medical Reviewer not only provides a medical
opinion that determines the complaint filing status, but also evaluates the complaint and MDR, as
stated in your firm&#146;s procedures. Therefore, Staar must provide training for all of your Medical
Reviewers in their procedures.


<P align="center" style="font-size: 10pt; display: none">10
<!-- PAGEBREAK -->

<P align="left" style="font-size: 12pt"><U><B>MDR Regulations</B></U>


<P align="left" style="font-size: 12pt">A review of Staar&#146;s complaint files reveals systemic problems with your complaint handling
procedures. These problems result in a failure to identify and adequately report MDR reportable
events.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">I.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to submit medical device reports to FDA within thirty days of receipt or
otherwise becoming aware of information, from any source, that reasonably suggests that a
device you market may have caused or contributed to a death or serious injury, in violation of
<B>21 C.F.R. &#167; 803.50(a)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your firm is not reporting adverse events when a physician reports a diopter
change or refractive surprise less than 2.5 diopters. For example, complaint 401056
reported a diopter change of 1.5 diopters; however, no MDR was filed for this event.
<U>See</U> Form&nbsp;483 Item&nbsp;16(a).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states that you report all refractive
changes. However, your MDR procedure does not state that refractive surprise or
diopter change less than 2.5 diopters is reported as an MDR. The procedure defines
a reportable refractive surprise as one where the &#147;difference between the targeted
refraction and actual refraction of greater than 2.5D.&#148;


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">B.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Your firm is not reporting adverse events when the patient had a preexisting
condition. <U>See</U> Form&nbsp;483 Item&nbsp;16(b).</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your firm&#146;s November&nbsp;2004 response states that Staar is now reporting adverse
events associated with pre-existing conditions. However, you are still not
reporting all information required by FDA in the MDR regulations. You are
reporting only the secondary surgical intervention needed to correct the actual
reportable event.


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">II.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You have failed to provide FDA with all information that is reasonably known to the
manufacturer, in violation of <B>21 C.F.R. &#167; 203.S0(b )(1)</B>.</TD>
</TR>

</TABLE>


<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="8%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">A.</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>You did not include all devices involving an adverse event in an MDR report.
For example, when an IOL stuck in a cartridge, only the IOL or cartridge was
documented in the MDR report even though both devices had been returned for
evaluation. <U>See</U> Form&nbsp;483, Item&nbsp;17.</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:16%; font-size: 12pt">Your November&nbsp;2004 response to this item states that your firm is reporting all
devices involved with an adverse event in MDR reports to FDA. However, you are not
reporting your injectors when they are involved in an adverse event. You are
reporting MDRs that only list the lens as the defective device, even though the
injector is also involved in the incident.


<P align="center" style="font-size: 10pt; display: none">11
<!-- PAGEBREAK -->

<P align="left" style="font-size: 12pt"><U><B>CONCLUSION</B></U>


<P align="left" style="font-size: 12pt">Please be aware that it is your responsibility for ensuring that Staar and its medical devices are
in compliance with the Act and FDA regulations. If you do not immediately come into compliance
with the law, FDA is prepared to seek appropriate legal and equitable remedies under the Act,
including seizure and injunction.


<P align="left" style="font-size: 12pt">To facilitate your compliance with the Act and FDA regulations, FDA requests that, within ten (10)
calendar days from your receipt of this letter, you provide responses to each of the violations
listed above and include all documentation supporting your position. Please send your written
response to: <B>19701 Fairchild, Irvine, California, 92612-2445</B>, <B>and The Center for Devices and
Radiological Health (HFZ-300), Room&nbsp;245, 2094 Gaither Road, Rockville, Maryland 20850</B>.


<P align="left" style="font-size: 12pt">If you have any questions concerning this letter, please call ***, Los Angeles District, at (949)
***.


<P align="left" style="font-size: 12pt">Sincerely,

<DIV align="center">
<TABLE style="font-size: 12pt" cellspacing="0" border="0" cellpadding="0" width="95%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="50%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="45%">&nbsp;</TD>
</TR>

<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom" style="font-size: 12pt">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">***<BR>
***<BR>
Los Angeles District Office<BR>
U.S. Food and Drug Administration
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">***<BR>
***<BR>
Office of Compliance, CDRH<BR>
U.S. Food and Drug Administration</TD>
</TR>
<TR valign="bottom" style="font-size: 12pt">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>



<P align="center" style="font-size: 10pt; display: none">12


<!-- v.050305 -->
</BODY>

</BODY>
</HTML>
</TEXT>
</DOCUMENT>
</SUBMISSION>
