<SEC-DOCUMENT>0001144204-14-051983.txt : 20141007
<SEC-HEADER>0001144204-14-051983.hdr.sgml : 20141007
<ACCEPTANCE-DATETIME>20140821174548
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001144204-14-051983
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20140821

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:		CORRESP

	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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<TYPE>CORRESP
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<P STYLE="margin: 0"></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><IMG SRC="image_001.jpg" ALT=""><B>&nbsp;</B></P>

<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">August 21, 2014</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; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>[VIA EDGAR]</U></B></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">Mr. Kevin L. Vaughn</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">United States Securities and Exchange Commission<BR>
Division of Corporation Finance</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">100 F Street, N.E.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Washington, D.C. 20549</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><B>Re:</B></TD><TD STYLE="text-align: justify"><B>STAAR Surgical Company</B></TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>Form 10-K for the fiscal year ended January
3, 2014</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>Filed March 12, 2014</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>Form 10-Q for the quarter ended July
4, 2014</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>Filed July 31, 2014</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>File No. 0-11634</B></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">Dear Mr. Vaughn:</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; text-indent: 0.5in">This letter responds to the comment letter
(the &ldquo;Comment Letter&rdquo;) dated August 7, 2014 regarding the comments of the staff of the Division of Corporation Finance
(the &ldquo;Staff&rdquo;) of the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) with respect to the above referenced
(i) Annual Report on Form 10-K for the fiscal year ended January 3, 2014 of STAAR Surgical Company (&ldquo;STAAR,&rdquo; or the
&ldquo;Company&rdquo;) and (ii) Quarterly Report on Form 10-Q for the second quarter ended July 4, 2014 (the &ldquo;2014 Form 10-Q&rdquo;)
of the Company. For the convenience of the Staff, we have reproduced the Staff&rsquo;s comment in bold type and have followed such
comment with the Company&rsquo;s response.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>Form 10-Q for the quarterly period
ended July 4, 2014</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>Management&rsquo;s Discussion and
Analysis of Financial Condition and Results of Operations, page 12</U></B></P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><B>1.</B></TD><TD STYLE="text-align: justify"><B>We see disclosures on page 22 that on May 27, 2014 you received a Warning Letter from the FDA
citing violations of current good manufacturing practice regulations that were identified by FDA during an inspection of your manufacturing
facility in Monrovia, California between February 10, 2014 and March 21, 2014. Given you disclosed on page 11 that &ldquo;As of
June 2014, all international production has been consolidated into the Monrovia site. Aliso Viejo is expected to integrate into
Monrovia in the middle of 2015&rdquo;, it appears your Monrovia manufacturing facility is very important to your current and future
product manufacturing capabilities. Accordingly, in future filings please revise your Management&rsquo;s Discussion and Analysis
disclosures to quantify the actual and/or expected impact of Monrovia site FDA violations, as well as your remediation thereof,
on your liquidity, results of operations and capital resources. Refer to Item 303 of Regulation S-K.</B></TD></TR></TABLE>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">United States Securities and Exchange Commission</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">August 21, 2014</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Page 2</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">&nbsp;</P>



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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">The Company acknowledges the Staff&rsquo;s
request to quantify the actual and/or expected impact of Monrovia site FDA violations, including the remediation thereof, on our
liquidity, results of operations and capital resources in our future Management&rsquo;s Discussion and Analysis disclosures in
accordance with Item 303 of Regulation S-K, and will comply accordingly.</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; text-indent: 0.5in">As you may already know, the Warning Letter
does not prohibit STAAR from selling any of its currently approved products in the U.S. Also, we noted in our 2014 Form 10-Q, the
following:</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 0.6in; text-align: justify">&ldquo;The Warning Letter provides
that, until the Company addresses the deficiencies to the FDA&rsquo;s satisfaction, the FDA will not approve premarket applications
(&ldquo;PMAs&rdquo;) for the Company&rsquo;s Class III devices where the applications are reasonably related to the cGMP violations
cited in the Warning Letter. The FDA has not provided us with a timeline for follow-up after the advisory panel meeting regarding
a timeline for a decision on the PMA Supplement for the TICL, which has remained pending for over eight years, and it is unclear
whether the Warning Letter will ultimately impact the timing of a potential approval. While the PMA supplement remains pending,
we cannot predict when, or if, the FDA will grant approval of the TICL for use in the United States.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.6in; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">If circumstances change, we will update this disclosure.</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; text-indent: 0.5in">If you have any questions or comments regarding
this response, please feel free to contact me.</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; text-align: left; text-indent: 0in">Sincerely,</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">STAAR Surgical Company</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">/s/ Stephen P. Brown
</P>

<HR ALIGN="LEFT" NOSHADE SIZE="1" STYLE="color: Black; width: 20%; margin-top: 3pt; margin-bottom: 3pt">
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">Stephen P. Brown</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">Vice President</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">Chief Financial Officer</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left">cc:</TD><TD STYLE="text-align: justify">David Burton, the Commission</TD>
</TR></TABLE>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Samuel J. Gesten, STAAR Surgical Company</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; text-indent: 0.5in">&nbsp;</P>

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

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
