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<ACCESSION-NUMBER>0000718937-05-000006
<TYPE>8-K
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<PERIOD>20050201
<ITEMS>7.01
<FILING-DATE>20050202
<DATE-OF-FILING-DATE-CHANGE>20050201
<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>05567044
</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>
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<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>f8k020105.htm
<DESCRIPTION>FORM 8-K 02/01/05
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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>UNITED STATES </FONT></H1>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>SECURITIES AND
EXCHANGE COMMISSION </FONT></H1>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=3>Washington, D.C. 20549 </FONT></H1>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>FORM 8-K </FONT></H1>

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<A NAME=A005></A>
<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>CURRENT REPORT </FONT></H1>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934 </FONT></H1>

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<P ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Date of Report (Date of
earliest event reported): February 1, 2005 </FONT></P>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>STAAR SURGICAL COMPANY </FONT></H1>

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<P ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>(Exact name of
registrant as specified in its charter) </FONT></P>

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<TD align=center width="33%"><FONT face="Times New Roman, Times, Serif" size=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Delaware</FONT></TD>
<TD align=center width="33%"><FONT face="Times New Roman, Times, Serif" size=2>0-11634</FONT></TD>
<TD align=center width="34%"><FONT face="Times New Roman, Times, Serif" size=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;95-3797439</FONT></TD></TR>
<TR vAlign=bottom>
<TD align=center><FONT face="Times New Roman, Times, Serif" size=1>&nbsp;&nbsp;(State or other jurisdiction</FONT></TD>
<TD align=center><FONT face="Times New Roman, Times, Serif" size=1>(Commission File Number)</FONT></TD>
<TD align=center><FONT face="Times New Roman, Times, Serif" size=1>(I.R.S. Employer Identification No.)</FONT></TD></TR>
<TR vAlign=bottom>
<TD align=center><FONT face="Times New Roman, Times, Serif" size=1>of incorporation or organization)</FONT></TD>
<TD align=center><FONT face="Times New Roman, Times, Serif" size=1></FONT></TD></TR>
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<P align=center><FONT face="Times New Roman, Times, Serif" size=2>1911 Walker Avenue,&nbsp;Monrovia,&nbsp;California,&nbsp;&nbsp;&nbsp;91016</FONT></P>

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<P align=center><FONT face="Times New Roman, Times, Serif" size=1>(Address of principal executive offices)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Zip Code) </FONT></P>
<BR>
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<P align=center><FONT face="Times New Roman, Times, Serif" size=1>(Registrant's telephone number, including area code): </FONT><FONT face="Times New Roman, Times, Serif" size=2>(626) 303-7902 </FONT></P>
<BR>
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<P><FONT face="Times New Roman, Times, Serif" 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 face="Times New Roman, Times, Serif" size=2>[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </FONT></P>
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<P><FONT face="Times New Roman, Times, Serif" size=2>[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </FONT></P>

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<P><FONT face="Times New Roman, Times, Serif" size=2>[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </FONT></P>

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<P><FONT face="Times New Roman, Times, Serif" size=2>[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </FONT></P>

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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=3>Item 7.01. Regulation FD
Disclosure. </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;As
previously announced, on September 23, 2004, the FDA completed an inspection of the
Company&#146;s Monrovia, California manufacturing facility and issued a form &#147;FDA 483
Inspectional Observations&#148; (the &#147;483 Observations&#148;). On November 4, 2004,
the Company submitted its written response to the 483 Observations and provided
supplemental information on December 20, 2004. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;On
January 27, 2005, the Company and its representatives met with the FDA to update them on
the corrective actions taken by the Company in response to the 483 Observations. During
the meeting, the FDA gave no indication of the status of their review of our response or
the nature or timing of future communications to the Company. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;In
conversations, the FDA confirmed with the Company&#146;s regulatory
counsel with respect to the Collamer material that &#147;materials issues with regard to
stability have been addressed to the FDA&#146;s satisfaction.&#148; </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;On
December 16, 2004, the Company submitted to the FDA a supplement to the Company&#146;s
investigational device exemptions application for the STAAR Myopic Implantable Contact
Lens (ICL&#153;). The supplement requested permission for each of the active clinical
centers to continue enrollment of eyes in the ICL clinical investigation while the
pre-market approval is pending with the FDA so that the physicians may continue to expand
on their clinical experience with implantation of the ICL. On January 14, 2004, the FDA
approved the supplement allowing 18 investigational sites to enroll a combined total of 75
additional eyes each month. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Until
the FDA is satisfied with the adequacy of the Company&#146;s corrective action, it may
take further actions which could include conducting another inspection, seizure of the
Company&#146;s products, injunction of the Monrovia facility to compel compliance (which
may include suspension of production operations and/or recall of products), or other
actions. Such actions could have a material adverse effect on the Company&#146;s
established lines of business, results of operations and liquidity. Furthermore, until the
FDA is satisfied with the Company&#146;s response, it is unlikely to grant the Company
approval to market the ICL in the United States. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The
Company is not able to predict whether the FDA will conclude that the Company&#146;s
corrective actions to date or those included in its response to the 483 Observations
satisfactorily resolve its concerns. Nor can the Company predict the likelihood, nature
of, or timing of any additional action by the FDA or the impact of the 483 Observations or
any other FDA action on the Company&#146;s established lines of business, results of the
operations or liquidity or the approval of the ICL for the United States market. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The
business of the Company is subject to numerous risks and uncertainties that are beyond its
control, including, but not limited to, those set forth above and in the other reports
filed by the Company with the Securities and Exchange Commission. Such risks and
uncertainties could have a material adverse effect on the Company&#146;s business,
financial condition, operating results and cash flows. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The
information in this Current Report on Form 8-K will not be treated as &#147;filed&#148;
for the purposes of Section 18 of the Securities Exchange Act of 1934 (the &#147;Exchange
Act&#148;) or otherwise subject to the liabilities of that section. This information will
not be incorporated by reference into a filing under the Securities Act of 1933, or into
another filing under the Exchange Act. </FONT></P>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=3>SIGNATURES </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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 thereunto duly authorized. </FONT></P>

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<TD width="10%"><FONT face="Times New Roman, Times, Serif" size=2>Date:</FONT></TD>
<TD width="40%"><FONT face="Times New Roman, Times, Serif" size=2>February 1, 2005 </FONT></TD>
<TD width="50%"><FONT face="Times New Roman, Times, Serif" size=2><B>STAAR SURGICAL COMPANY </B><BR><BR><BR>By: /s/ John Bily <BR>&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;<BR>John Bily <BR>Chief Financial Officer </FONT></TD></TR>
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