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 29, 2005 |
STAAR Surgical Company
__________________________________________
(Exact name of registrant as specified in its charter)
| Delaware | 0-11634 | 95-3797439 |
|
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
| 1911 Walker Ave, Monrovia, California | 91016 | |
|
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
| Registrant’s telephone number, including area code: | 626-303-7902 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01 Regulation FD Disclosure.
On August 29, 2005, representatives of the Los Angeles District Office of the United States Food and Drug Administration (the "FDA") commenced an inspection of the Company’s Monrovia, California facility. The FDA’s inspection will include both a pre-approval inspection in connection with the Company’s premarket approval application for the VISIAN® ICL and an audit of the Company’s compliance with the FDA’s Quality System Regulation and Medical Device Reporting regulations.
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 hereunto duly authorized.
| STAAR Surgical Company | ||||
| August 29, 2005 | By: |
/s/ David Bailey
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| Name: David Bailey | ||||
| Title: Chief Executive Officer | ||||