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): October 6, 2003
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)
(626) 303-7902
(Registrant's telephone number, including area code)
Item 7. Financial Statements and Exhibits
(c) Exhibits
Exhibit Number Description
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99.1 Press Release dated October 6, 2003.
Item 9. Regulation FD Disclosure
On October 6, 2003, STAAR Surgical Company (the "Company") issued a press
release announcing that the U.S. Food and Drug Administration (the "FDA")
Ophthalmic Devices Panel of the Center for Devices and Radiological Health,
recommended that the Company's Implantable Contact Lens (ICL), a phakic implant
used to correct refractive errors, be approved with conditions for use in
correcting myopia in the range of -3 diopters to -15 diopters and reducing
myopia in the range of -15 diopters to -20 diopters. The FDA will consider these
recommendations as it completes its expedited review of the ICL Pre-Market
Approval application, which the Company submitted on May 8, 2003. However, there
can be no assurance that the FDA will follow the recommendations of the
Ophthalmic Devices Panel.
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: October 7, 2003 STAAR SURGICAL COMPANY
By: /s/ John Bily
_________________________
John Bily
Chief Financial Officer
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Exhibit Index
EXHIBIT NUMBER DESCRIPTION
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99.1 Press Release dated October 6, 2003.
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