<SUBMISSION>
<ACCESSION-NUMBER>0001299933-05-003380
<TYPE>8-K
<PUBLIC-DOCUMENT-COUNT>2
<PERIOD>20050705
<ITEMS>7.01
<ITEMS>8.01
<ITEMS>9.01
<FILING-DATE>20050711
<DATE-OF-FILING-DATE-CHANGE>20050711
<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>05946902
</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_5737.htm
<DESCRIPTION>LIVE FILING
<TEXT>
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<TITLE> STAAR Surgical Company (Form: 8-K) </TITLE>
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		UNITED STATES<BR>
	SECURITIES AND EXCHANGE COMMISSION
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<BR>
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	WASHINGTON, D.C. 20549
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	FORM 8-K
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	CURRENT REPORT
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	Pursuant to Section&nbsp;13 or 15(d) of the Securities Exchange Act of 1934
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	Date of Report (Date of Earliest Event Reported):
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	&nbsp;
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	July 5, 2005
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	STAAR Surgical Company
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<BR>__________________________________________<BR>
	(Exact name of registrant as specified in its charter)
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	Delaware
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	0-11634
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	95-3797439
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_____________________<BR>
	(State or other jurisdiction
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_____________<BR>
	(Commission
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______________<BR>
	(I.R.S. Employer
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	of incorporation)
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	File Number)
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	Identification No.)
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	1911 Walker Ave, Monrovia, California
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	&nbsp;
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	91016
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_________________________________<BR>
	(Address of principal executive offices)
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	&nbsp;
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___________<BR>
	(Zip Code)
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	Registrant&#146;s telephone number, including area code:
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	626-303-7902
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	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
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	&nbsp;
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<!-- 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>
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<B>
	Item 7.01 Regulation FD Disclosure.
</B>
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      On July 11, 2005, the Company published a press release announcing its receipt of a letter from the United States Food and Drug Administration.  A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by this reference.
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<B>
	Item 8.01 Other Events.
</B>
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<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.<br><br>      Between July 28 and September 23, 2004 the FDA conducted its most recent inspection of STAAR&#x2019;s Monrovia, California facility.  During this inspection the FDA investigators observed violations of the FDA&#x2019;s Quality System Regulations and Medical Device Reporting Regulations and documented these observations in a List of Inspectional Observations ("Form 483") delivered to STAAR.  STAAR addressed the questions and issues raised by the Form 483 in its responses provided to the FDA in November 2004 and February 2005. <br><br>      On July 5, 2005 STAAR received a letter from the FDA stating, among other things, that STAAR&#x2019;s earlier responses reveal that it has "failed to adequately correct numerous violations" noted on the Form 483.  The FDA letter goes on to state that the "FDA is gravely concerned about Staar&#x2019;s serious, continuing violations and is prepared to seek the appropriate remedies under the Act."  The FDA also indicates that this letter is its final attempt to notify STAAR of its non-compliance and gives STAAR ten calendar days from receipt of the letter to provide its responses and supporting documentation.<br><br>     STAAR takes all communications from the FDA seriously and intends to respond promptly to this letter.  While STAAR cannot predict the FDA&#x2019;s reaction to STAAR&#x2019;s response, STAAR believes that the FDA will pursue enforcement action against STAAR if it finds the response to be inadequate in any material respect.  This action, if taken, would most likely have a material and adverse impact on STAAR and its prospects.<br><br>     STAAR believes that the FDA is unlikely to approve marketing of the VISIAN&#174; ICL in the United States 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.  In addition, enforcement or other proceedings may restrict STAAR&#x2019;s established domestic lines of business.<br><br>     STAAR&#x2019;s response to the FDA&#x2019;s letter will include, among other things, data gathered by STAAR and information about corrective actions taken by STAAR following the 2004 inspection.  There can be no assurance that STAAR&#x2019;s responses to the most recent letter will resolve all of the open issues to the FDA&#x2019;s satisfaction, although STAAR is committed to use all efforts to achieve that result.  Even if the FDA does accept STAAR&#x2019;s corrective action, the FDA may initiate future or additional actions and has specifically reserved the right to do so in its most recent letter.<br>
</FONT>
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	Item 9.01 Financial Statements and Exhibits.
</B>
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<FONT SIZE="2">
Exhibit<br>Number     Description of Exhibit<br>99.1       Press release dated July 11, 2005.   <br>	<br>
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<B>
	SIGNATURES
</B>
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	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.
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	&nbsp;
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	&nbsp;
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	&nbsp;
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	&nbsp;
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	&nbsp;
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<FONT SIZE="2">
	STAAR Surgical Company
</FONT>
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	&nbsp;&nbsp;
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</TD>
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	&nbsp;
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	&nbsp;
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<FONT SIZE="2">
	&nbsp;
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<I>
	July 11, 2005
</I>
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</TD>
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<FONT SIZE="2">
	&nbsp;
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<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	By:
</I>
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</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
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<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
<I>
	/s/David Bailey
</I>
<BR>
</FONT>
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<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
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<TD ALIGN="LEFT" VALIGN="TOP">
<FONT SIZE="2">
	&nbsp;
</FONT>
</TD>
<TD>
<FONT SIZE="2">
	&nbsp;
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<FONT SIZE="2">
	&nbsp;
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	&nbsp;
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<FONT SIZE="2">
	&nbsp;
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<FONT SIZE="2">
	&nbsp;
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<I>
	Name: David Bailey
</I>
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	&nbsp;
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	&nbsp;
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<I>
	Title: Chief Executive Officer
</I>
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	Exhibit&nbsp;Index
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<B>
	Exhibit No.
</B>
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<FONT SIZE="1">
	&nbsp;
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<TD NOWRAP ALIGN="LEFT">
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<B>
	Description
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	&nbsp;
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	99.1
</DIV>
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<FONT SIZE="2">
	&nbsp;
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<TD ALIGN="LEFT" VALIGN="TOP" WIDTH="77%">
<FONT SIZE="2">
Press Release dated July 11, 2005.
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit1.htm
<DESCRIPTION>EX-99.1
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 3.2//EN">
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<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">

<DIV align="center">
<TABLE style="font-size: 12pt" cellspacing="0" border="0" cellpadding="0" width="95%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="8%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="41%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="41%">&nbsp;</TD>
</TR>
<TR style="font-size: 12pt" valign="bottom">
    <TD nowrap align="left" style="border-bottom: 1px solid #000000">CONTACT:</TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="center" style="border-bottom: 1px solid #000000"><B>Investors</B></TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="center" style="border-bottom: 1px solid #000000"><B>Media</B></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">
&nbsp;</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">EVC Group<BR>
Douglas Sherk, 415-896-6820<BR>
Jennifer Beugelmans, 415-896-6820
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">EVC Group<BR>
Steve DiMattia, 917-620-0590<BR>
<BR></TD>
</TR>

<!-- End Table Body -->
</TABLE>
</DIV>



<P align="left" style="font-size: 12pt">FOR IMMEDIATE RELEASE


<P align="center" style="font-size: 12pt"><B>STAAR SURGICAL REPORTS ON LATEST COMMUNICATIONS WITH FDA</B>



<P align="center" style="font-size: 12pt"><B><I>Company to Provide FDA with Update on Recent Compliance Programs and Commitment by Friday, July&nbsp;15,<BR>
2005</I></B>



<P align="center" style="font-size: 12pt"><B><I>Conference Call Scheduled for 10 a.m. Eastern Time Today</I></B>



<P align="left" style="font-size: 12pt">MONROVIA, CA, July&nbsp;11, 2005&#151;STAAR Surgical Company (Nasdaq: STAA) today announced that it has
received a letter from the Food and Drug Administration (FDA)&nbsp;in response to the Company&#146;s
responses, dated November&nbsp;4, 2004 and February&nbsp;11, 2005, to the FDA&#146;s Form&nbsp;483 issued in September
2004. This letter, received on July&nbsp;5, 2005, is the Agency&#146;s first formal communication to the
Company since the receipt of the Form&nbsp;483 following the closure of the Monrovia audit in September
2004. In the letter the FDA states, among other things, that STAAR&#146;s earlier responses reveal that
the company has &#147;failed to adequately correct numerous violations&#148; noted on the Form&nbsp;483. The FDA
letter also states that the &#147;FDA is gravely concerned about STAAR&#146;s serious, continuing violations
and is prepared to seek the appropriate remedies under the Act.&#148; The FDA also indicates that this
letter is its final attempt to notify STAAR of its non-compliance and gives STAAR 10 calendar days
following the receipt of the letter to provide its responses and supporting documentation.


<P align="left" style="font-size: 12pt">STAAR will submit its response to the FDA&#146;s letter within the 10-day deadline. The response will
include, among other things, data gathered by STAAR and information about ongoing corrective
actions taken by STAAR following the latest update submitted to FDA in February&nbsp;2005. There can
be no assurance that STAAR&#146;s responses to the most recent letter will resolve all of the open
issues to the FDA&#146;s satisfaction, although STAAR is committed to using all resources to achieve
that result.


<P align="left" style="font-size: 12pt">STAAR cannot predict the FDA&#146;s reaction to STAAR&#146;s response, but believes that the FDA will pursue
enforcement action against the Company if it finds the response inadequate. This action, if taken,
would most likely have a material and adverse impact upon STAAR and its prospects.


<P align="left" style="font-size: 12pt">STAAR continues to believe that the FDA will not grant final approval to market the VISIAN&#174; ICL in
the United States until all compliance issues have been resolved.


<P align="left" style="font-size: 12pt"><U><B><I>Conference Call</I></B></U>
<BR>
The Company will host a conference call and webcast today<B><I>, July&nbsp;11, 2005 at 10:00&nbsp;a.m. Eastern Time</I></B>
to provide further details on the FDA letter and review recent actions taken by the Company to
improve its regulatory and compliance programs. The dial-in number for the conference call is
800-240-2430 for domestic participants and 303-262-2138 for international participants.


<P align="left" style="font-size: 12pt">A taped replay of the conference call will also be available beginning approximately one hour after
the call&#146;s conclusion and will remain available through 11:59&nbsp;p.m. Pacific Time on Thursday, July
14, 2005 and can be accessed by dialing 800-405-2236 for domestic callers and 303-590-3000 for
international callers, both using passcode 11034757#. To access the live webcast of the call, go
to STAAR Surgical&#146;s website at <U>www.staar.com</U>. An archived webcast will also be available at
<U>www.staar.com.</U>


<P align="left" style="font-size: 12pt"><U><B><I>About STAAR Surgical</I></B></U>
<BR>
STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive
ophthalmic products employing proprietary technologies.


<P align="left" style="font-size: 12pt"><U><B><I>Safe Harbor</I></B></U>
<BR>
All statements in this press release that are not statements of historical fact are forward-looking
statements, including statements about STAAR&#146;s regulatory compliance plans, 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 FDA on July&nbsp;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&#146;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.



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