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): August 13, 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) (626) 303-7902 (Registrant's telephone number, including area code) -1- Item 9. Regulation FD Disclosure On July 28, 2004, the U.S. Food and Drug Administration (FDA) commenced a re-audit of the Company's Monrovia, California manufacturing facility. The audit has continued since that date. On Friday, August 13, 2004, the Company was notified by the FDA audit team that, due to scheduling conflicts, the audit would be partially interrupted over the next two weeks and, accordingly, would not be concluded until later than anticipated. At this time, no definitive date has been provided by the FDA for completion of the audit. The Company is committed to working closely with the FDA in a constructive manner and to returning to compliance with the FDA guidelines. The information in this Current Report on Form 8-K 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 Item 9 of this Current Report. -2- 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. STAAR SURGICAL COMPANY Date: August 16, 2004 By: /s/ John Bily -------------------------- John Bily, Chief Financial Officer -3-