-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KgC2HhEA6+VVBnixUIwc0bzWRoB9D+fIbFFV8DN0RiYE836aZMFBg+ARVz9qYn7v XjiCEvxy8Br3ZaU0WNVoPQ== 0001169232-04-004157.txt : 20040817 0001169232-04-004157.hdr.sgml : 20040817 20040816215350 ACCESSION NUMBER: 0001169232-04-004157 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20040813 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20040817 FILER: COMPANY DATA: COMPANY CONFORMED NAME: STAAR SURGICAL COMPANY CENTRAL INDEX KEY: 0000718937 STANDARD INDUSTRIAL CLASSIFICATION: OPHTHALMIC GOODS [3851] IRS NUMBER: 953797439 STATE OF INCORPORATION: DE FISCAL YEAR END: 0101 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-11634 FILM NUMBER: 04980517 BUSINESS ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 BUSINESS PHONE: 8183037902 MAIL ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 8-K 1 d60497_8-k.txt CURRENT REPORT 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- -----END PRIVACY-ENHANCED MESSAGE-----