<SUBMISSION>
<ACCESSION-NUMBER>0001299933-05-003823
<TYPE>8-K/A
<PUBLIC-DOCUMENT-COUNT>3
<PERIOD>20050728
<ITEMS>7.01
<ITEMS>8.01
<FILING-DATE>20050729
<DATE-OF-FILING-DATE-CHANGE>20050729
<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/A
<ACT>34
<FILE-NUMBER>000-11634
<FILM-NUMBER>05982662
</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/A
<SEQUENCE>1
<FILENAME>htm_6179.htm
<DESCRIPTION>LIVE FILING
<TEXT>
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<TITLE> STAAR Surgical Company (Form: 8-K/A) </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/A
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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 28, 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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<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>
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<B>
	Item 7.01 Regulation FD Disclosure.
</B>
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On July 28, 2005, the Company published a press release related to a letter received from the the Office of Device Evaluation of the U.S. Food and Drug Administration (the "FDA").  A copy of the press release is furnished as Exhibit 99.1 hereto. <br><br>
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<B>
	Item 8.01 Other Events.
</B>
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On July 28, 2005, STAAR Surgical Company (the "Company") received a letter from the FDA Office of Device Evaluation stating that the FDA has reviewed the Company's pre-market approval application ("PMA") for the STAAR Myopic VISIAN ICL(TM) and has determined that the PMA is approvable subject to an FDA inspection that finds the Company's manufacturing facilities, methods and controls in compliance with the applicable requirements of the FDA's Quality System Regulation.<br><br>The ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The models of the STAAR Myopic Visian ICL(TM) subject to the PMA are indicated for the correction of myopia in adults with myopia ranging from -3.0 to -15.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21-45 years of age with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.<br><br>A copy of the letter from the FDA Office of Device Evaluation is attached to this report as Exhibit 99.2 and is incorporated herein by this reference.  <br><br>As previously reported, on July 5, 2005, the Company received a letter from the FDA informing the Company that it had failed to adequately address observations made at the conclusion of the FDA&#x2019;s most recent audit of the Company's Monrovia facility on September 23, 2004, and that based on the Company&#x2019;s responses made by letter in November 2004 and February 2005 the Company was in violation of the FDA&#x2019;s Quality Systems Regulation and Medical Device Reporting regulations.  The Company responded to the letter on July 15, 2005.  The Company cannot predict the timing or substance of the FDA&#x2019;s reaction to the Company'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 the Company and its prospects. The Company continues to believe that the FDA will not grant the Company final approval to market the VISIAN(TM) ICL in the United States until all compliance issues have been resolved. <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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	STAAR Surgical Company
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	&nbsp;&nbsp;
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<I>
	July 28, 2005
</I>
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	&nbsp;
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<I>
	By:
</I>
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</TD>
<TD>
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	&nbsp;
</FONT>
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<I>
	/s/ David Bailey
</I>
<BR>
</FONT>
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	&nbsp;
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</TD>
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	&nbsp;
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<FONT SIZE="2">
	&nbsp;
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	&nbsp;
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<FONT SIZE="2">
<I>
	Name: David Bailey
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<I>
	Title: Chief Executive Officer
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	Exhibit&nbsp;Index
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	Exhibit No.
</B>
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	&nbsp;
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	Description
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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 28, 2005.
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	99.2
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<FONT SIZE="2">
	&nbsp;
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<FONT SIZE="2">
Letter from U.S. Food and Drug Administration Office of Device Evaluation dated July 28, 2005.
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<FILENAME>exhibit1.htm
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<BODY style="font-family: 'Times New Roman',Times,serif">

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    <TD width="82%">&nbsp;</TD>
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<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px"><FONT style="font-size: 12pt">CONTACT:</FONT>
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top"><FONT style="font-size: 12pt">Investors Media<BR>
EVC Group EVC Group<BR>
Douglas Sherk, 415-896-6820Steve DiMattia, 646-277-8706<BR>
Jennifer Beugelmans, 415-896-6820</FONT></TD>
</TR>
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<P align="left" style="font-size: 12pt">FOR IMMEDIATE RELEASE


<P align="center" style="font-size: 12pt"><B>STAAR SURGICAL COMPANY RECEIVES APPROVABLE LETTER FROM FDA FOR VISIAN ICL</B>&#153;<BR>
<B><I>Final approval to begin commercial distribution subject<BR>
To FDA inspection</I></B>



<P align="left" style="font-size: 12pt">MONROVIA, CA., July&nbsp;28, 2005 STAAR Surgical Company (Nasdaq:STAA) today reported that the U.S. Food
and Drug Administration (FDA)&nbsp;has reviewed the Company&#146;s pre-market approval application (PMA)&nbsp;for
the STAAR Myopic VISIAN ICL&#153; and has determined that the PMA is approvable subject to an FDA
inspection that finds the Company&#146;s manufacturing facilities, methods and controls in compliance
with the applicable requirements of the FDA&#146;s Quality System Regulation.


<P align="left" style="font-size: 12pt">The ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye.
The models of the STAAR Myopic Visian ICL&#153; subject to the PMA are indicated for the correction of
myopia in adults with myopia ranging from -3.0 to -15.0 diopters with astigmatism less than or
equal to 2.5 diopters at the spectacle plane and the reduction of myopia in adults with myopia
ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5
diopters at the spectacle plane, in patients 21-45&nbsp;years of age with anterior chamber depth (ACD)
3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to
implantation.


<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. STAAR&#146;s products are used by ophthalmic
surgeons and include the revolutionary VISIAN ICL&#153; as well as innovative products designed to
improve patient outcomes for cataracts and glaucoma. STAAR&#146;s ICL has received CE Marking, is
approved for sale in 41 countries and has been implanted in more than 40,000 eyes worldwide.


<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 any projections of earnings, revenue, cash or other financial items, any
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, any statements regarding future economic conditions or performance, 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, which could affect commercial distribution of the
VISIAN ICL in the U.S. and could result in restrictions on our ability to continue our business as
well as harm to our reputation and stock price, 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, market acceptance of our redesigned three-piece Collamer IOL and insertion system, 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 our control,
including those detailed from time to time in our reports filed with the Securities and Exchange
Commission. STAAR assumes no obligation to update these forward-looking statements to reflect
future events or actual outcomes and does not intend to do so.



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


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<TYPE>EX-99.2
<SEQUENCE>3
<FILENAME>exhibit2.htm
<DESCRIPTION>EX-99.2
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 12pt">Department of Health &#038; Human Services
</FONT>


<P align="left" style="margin-left:76%; font-size: 12pt">Public Health Service
<BR>
9200 Corporate Boulevard
<BR>
Rockville MD 20850


<P align="center" style="font-size: 12pt">Jul 28 2005



<P align="left" style="font-size: 12pt">Helene Lamielle, M.D.
<BR>
Vice President of Scientific Affairs
<BR>
STAAR Surgical Company
<BR>
1911 Walker Avenue
<BR>
Monrovia, CA 91016

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    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">Re:
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">P030016<BR>
STAAR Myopic Visian ICL&#153; (Implantable Collamer Lens)<BR>
Models: ICM120, ICM125, ICM130, ICM135<BR>
Filed: May&nbsp;8, 2003</TD>
</TR>
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<P align="left" style="font-size: 12pt; text-indent: 4%">Amended: May&nbsp;29, July&nbsp;8, 10, and 15, August&nbsp;18, September&nbsp;3, 4, 11, 22 and 25,


<P align="left" style="font-size: 12pt; text-indent: 4%">2003, January&nbsp;26, August&nbsp;19, and December&nbsp;14, 2004, February&nbsp;1, June 1 and 2,


<P align="left" style="font-size: 12pt; text-indent: 4%">July&nbsp;19, and 27, 2005


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


<P align="left" style="font-size: 12pt">The Center for Devices and Radiological Health (CDRH)&nbsp;of the Food and Drug Administration (FDA)&nbsp;has
reviewed your premarket approval application (PMA)&nbsp;which requests approval for STAAR Myopic Visian
ICL&#153; (Implantable Collamer Lens) &#151; Models: ICMl2, ICM125, ICM130, and ICM135.


<P align="left" style="font-size: 12pt">We are pleased to inform you that CDRH has determined that the PMA is approvable subject to an FDA
inspection that finds the manufacturing facilities, methods and controls in compliance with the
applicable requirements of the Quality System Regulation (21 CFR Part&nbsp;820). If you have not already
done so, please notify CDRH as soon as possible in the form of an amendment to the PMA if there
will be a delay in setting up your manufacturing facility for production of the device, and provide
the expected date that the facility will be prepared for an FDA inspection. If you have any
questions regarding the status of your Quality System inspection please contact the Office of
Compliance at (240)&nbsp;276-0131, or your District Office.


<P align="left" style="font-size: 12pt">CDRH will issue an approval order after the inspectional findings have been reviewed and determined
to be acceptable. You may not begin commercial distribution of the device manufactured at your
facilities until you have received an approval order.


<P align="left" style="font-size: 12pt">There are other options in lieu of amending the PMA as indicated above and/or awaiting a CDRH
approval decision based upon the findings of an FDA inspection of the manufacturing facility. You
may choose to withdraw the PMA or you may treat this letter as a formal denial of approval. If you
choose the latter, you may request administrative


<P align="center" style="font-size: 10pt; display: none">1
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<P align="left" style="font-size: 12pt">review, either through a hearing or review by an independent advisory committee, under section
515(d)(4) and 515(g) of the Federal Food, Drug, and Cosmetic Act by filing a petition with the Food
and Drug Administration, Dockets Management Branch (HFA 305), Room&nbsp;1-23, 12420 Parklawn Drive,
Rockville, Maryland 20857, within 30&nbsp;days of the date you receive this letter. A petition for
administrative review must be submitted in accordance with general administrative procedures for
submission of documents to the Dockets Management Branch (21 CFR 10.20) and in the form of a
petition for reconsideration (21 CFR 10.33). After reviewing the petition, FDA will decide whether
to grant or deny the petition and will publish a notice of its decision in the FEDERAL REGISTER. If
FDA grants the petition, the notice will state the issues to be reviewed, the form of the review to
be used, the persons who may participate in the review, the time and place where the review will
occur, and other details.


<P align="left" style="font-size: 12pt">All amendments to the PMA should be submitted in triplicate to the address below and reference the
above PMA number to facilitate processing.



<P align="left" style="margin-left:16%; font-size: 12pt">PMA Document Mail Center (HFZ-401)
<BR>
Center for Devices and Radiological Health
<BR>
Food and Drug Administration
<BR>
9200 Corporate Blvd.
<BR>
Rockville, Maryland 20850


<P align="left" style="font-size: 12pt">If you have any questions concerning this approvable letter, please contact Kesia Alexander, Ph.D.
at (301)&nbsp;594-2053.



<P align="left" style="margin-left:42%; font-size: 12pt">Sincerely yours,



<P align="left" style="margin-left:42%; font-size: 12pt">/s/ David M. Whipple


<P>
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<TR valign="top" style="font-size: 12pt; color: #000000; background: transparent">
    <TD width="21%" style="background: transparent">&nbsp;</TD>
    <TD width="1%" nowrap align="right">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD>David M. Whipple</TD>
</TR>

</TABLE>



<P align="left" style="margin-left:42%; font-size: 12pt">Acting Director
<BR>
Division of Ophthalmic and Ear,



<P align="left" style="margin-left:42%; font-size: 12pt; text-indent: 1%">Nose and Throat Devices



<P align="left" style="margin-left:42%; font-size: 12pt">Office of Device Evaluation
<BR>
Center for Devices



<P align="left" style="margin-left:42%; font-size: 12pt; text-indent: 1%">and Radiological Health



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


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