<SEC-DOCUMENT>0001144204-15-007548.txt : 20150210
<SEC-HEADER>0001144204-15-007548.hdr.sgml : 20150210
<ACCEPTANCE-DATETIME>20150210172825
ACCESSION NUMBER:		0001144204-15-007548
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20150204
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20150210
DATE AS OF CHANGE:		20150210

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			STAAR SURGICAL CO
		CENTRAL INDEX KEY:			0000718937
		STANDARD INDUSTRIAL CLASSIFICATION:	OPHTHALMIC GOODS [3851]
		IRS NUMBER:				953797439
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1228

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-11634
		FILM NUMBER:		15595170

	BUSINESS ADDRESS:	
		STREET 1:		1911 WALKER AVE
		CITY:			MONROVIA
		STATE:			CA
		ZIP:			91016
		BUSINESS PHONE:		6263037902

	MAIL ADDRESS:	
		STREET 1:		1911 WALKER AVE
		CITY:			MONROVIA
		STATE:			CA
		ZIP:			91016

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	STAAR SURGICAL COMPANY
		DATE OF NAME CHANGE:	19920703
</SEC-HEADER>
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<FILENAME>v401080_8k.htm
<DESCRIPTION>FORM 8-K
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<P STYLE="margin: 0">&nbsp;&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION<BR>
WASHINGTON, D.C. 20549</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">FORM 8-K</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">CURRENT REPORT</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Pursuant to Section&nbsp;13 or 15(d) of
the Securities Exchange Act of 1934</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of Report (Date of Earliest Event Reported):
February 4, 2015</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><U>STAAR Surgical
Company</U></FONT><BR>
<FONT STYLE="font-size: 10pt">(Exact name of registrant as specified in its charter)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

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        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><U>Delaware</U><BR>
(State or other jurisdiction&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">of incorporation)</P></TD>
    <TD STYLE="width: 34%; font-size: 10pt; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><U>0-11634</U></FONT><BR>
    <FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;(Commission File Number)</FONT></TD>
    <TD STYLE="width: 33%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><U>95-3797439</U><BR>
(I.R.S. Employer&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Identification No.)</P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">1911 Walker Ave, Monrovia, California <BR>
(Address of principal executive offices)</FONT></TD>
    <TD STYLE="text-align: center; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><U>91016</U></FONT><BR>
<FONT STYLE="font: 10pt Times New Roman, Times, Serif">(Zip Code)</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><U>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Not
Applicable&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</U><BR>
Former name or former address, if changed since last report</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Wingdings">&uml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item 8.01 &#9;Other Events</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">As previously disclosed, STAAR received an FDA Warning
Letter, dated May 21, 2014, regarding compliance with current Good Manufacturing Practices at the Monrovia facility. Upon
receipt of this letter, STAAR initiated development and subsequent implementation of corrective action plans related to this
letter. Beginning on November 14, 2014 and continuing through February 4, 2015, the U.S. Food and Drug Administration (FDA)
inspected the Company&rsquo;s Monrovia facility as a follow-up to the 2014 Warning Letter and also as a post-approval
inspection regarding the approved PMA supplement that added the Monrovia facility as an alternate manufacturing facility for
the ICL. On February 4, 2015, at the conclusion of the inspections, the FDA issued a Form 483 with ten inspectional
observations. The observations focus primarily on the need for adherence to and improved procedures, processes and
documentation relating to design change, design transfer into specifications and production, verification and validation
associated with device design and production, improvement in Good Documentation Practices, and broader environmental
monitoring.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">STAAR is currently drafting a response to the FDA&rsquo;s observations
and is concurrently continuing to develop and implement its corrective action plans relating to the 2014 Warning Letter and the
Form 483. STAAR takes the matters identified by FDA seriously and will continue to work diligently to address the observations
identified in the Form 483 and 2014 Warning Letter. STAAR has enhanced and continues to enhance its overall quality program as
we focus on remediating all elements identified.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">There can be no assurance that the FDA will be satisfied with
the Company's response. Unless and until STAAR is able to correct outstanding issues to the FDA's satisfaction, the FDA may withhold
approval of new products such as the Toric ICL (TICL) or take additional regulatory or legal action against the Company. Any such
further action could have a material and negative impact on the Company&rsquo;s ongoing business and operations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>A Caution Concerning Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">This report on Form 8-K includes forward-looking
statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks,
uncertainties and other factors, including but not limited to risks related to whether the FDA or other regulatory
authorities will agree that steps taken or to be taken by STAAR to correct matters described in the 2014 Warning Letter and
Form 483 are adequate, whether STAAR can resolve any continuing concerns that may be expressed by the FDA or other regulatory
authorities in a timely manner and whether the FDA or other regulatory authorities decide to take further corrective or
disciplinary actions against STAAR. These risks, uncertainties and other factors could adversely cause the Company&rsquo;s
actual results and future business prospects to differ materially from those referred to in the forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements, and to review the Company&rsquo;s Annual Report on
Form 10-K for the year ended January 3, 2014, and also in the Company's Quarterly Report on Form 10-Q for the quarter ended
July 4, 2014, under the headings &quot;Risk Factors,&quot; and &ldquo;Management Discussion and Analysis of Financial
Condition and Results of Operations,&rdquo; both of which are on file with the Securities and Exchange Commission and
available in the &quot;Investor Information&quot; section of the Company&rsquo;s website (www.STAAR.com) under the heading
&quot;SEC Filings.&rdquo;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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.</P>

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    <TD STYLE="width: 47%; padding-right: 5.4pt; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">February 10, 2015</FONT></TD>
    <TD STYLE="width: 53%; padding-right: 5.4pt; padding-left: 5.4pt; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By:&nbsp;<U>/s/ Barry G. Caldwell</U></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Barry G. Caldwell</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="padding-right: 5.4pt; padding-left: 5.4pt; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;President and Chief Executive Officer</FONT></TD></TR>
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