UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2004
STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)
Delaware 0-11634 95-3797439
(State or other jurisdiction) (Commission File Number) (I.R.S. Employer
of incorporation or organization) Identification No.)
1911 Walker Avenue, Monrovia, California 91016
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code) (626) 303-7902
Item 5. Other Events and Regulation FD Disclosure.
THE BUSINESS OF STAAR SURGICAL COMPANY (THE "COMPANY") IS SUBJECT TO
NUMEROUS RISKS AND UNCERTAINTIES THAT ARE BEYOND ITS CONTROL, INCLUDING, BUT NOT
LIMITED TO, THOSE SET FORTH BELOW 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'S BUSINESS, FINANCIAL CONDITION,
OPERATING RESULTS AND CASH FLOWS.
Our operations are subject to periodic inspection by the U.S. Food and
Drug Administration (the "FDA"). Such inspection may result in the FDA ordering
changes in our business practices, which changes could be costly for the Company
and have a material adverse effect on our business and results of operations. On
December 29, 2003, the Company received a Warning Letter issued by the FDA, a
copy of which is attached hereto as Exhibit 99.1. While we are acting to quickly
correct the deficiencies identified in the Warning Letter, until the FDA is
satisfied with our response we will not be granted approval to market the ICL in
the United States and we may face FDA restrictions on our established domestic
lines of business. Even if the FDA approves our corrective action, the
publication of the Warning Letter or similar actions in the future could harm
our reputation and reduce sales.
Item 7. Financial Statements and Exhibits
(c) Exhibits.
Exhibit Number Description
-------------- -----------
99.1 Warning Letter dated December 22, 2003 from the U.S. Food and
Drug Administration.
99.2 Press release dated January 7, 2004.
99.3 Transcript of conference call conducted by STAAR Surgical
Company on January 7, 2004.
Item 9. Regulation FD Disclosure.
On January 7, 2004, the Company issued a press release announcing that it
is aggressively pursuing corrective actions to remedy issues cited in a Warning
Letter received by the Company on December 29, 2003 from the FDA. A copy of the
press release is attached as Exhibit 99.2 to this report and is incorporated
herein by this reference.
On January 7, 2004, the Company held a conference call to discuss the
Warning Letter. A transcript of the call is attached to this report as Exhibit
99.3 and is incorporated herein by this reference.
Item 12. Results of Operations and Financial Condition.
On January 7, 2004, the Company held a conference call during which it
gave information regarding revenues for the fourth fiscal quarter of 2003. A
transcript of the call is attached to this report as Exhibit 99.3 and is
incorporated herein by this reference.
The information furnished pursuant to Items 9 and 12 of this Current
Report on Form 8-K, including the exhibits, will not be treated as "filed" for
the purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange
Act") 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, unless that filing
expressly refers to specific information in this report.
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SIGNATURES
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.
Date: January 9, 2004 STAAR SURGICAL COMPANY
By: /s/ John Bily
___________________
John Bily
Chief Financial Officer
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Exhibit Index
EXHIBIT NUMBER DESCRIPTION
-------------- -----------
99.1 Warning Letter dated December 22, 2003 from the U.S. Food and
Drug Administration.
99.2 Press release dated January 7, 2004.
99.3 Transcript of conference call conducted by STAAR Surgical
Company on January 7, 2004.
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