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STAA > SEC Filings for STAA > Form 8-K on 2-Dec-2013All Recent SEC Filings

Show all filings for STAAR SURGICAL CO

Form 8-K for STAAR SURGICAL CO


2-Dec-2013

Regulation FD Disclosure


Item 7.01 Regulation FD Disclosure.

On November 21, 2013, STAAR Surgical Company received verbal notice from the FDA indicating the agency's intent to review STAAR's PMA Supplement regarding its toric ICL at the Ophthalmic Devices Agency Panel meeting scheduled for February 14, 2014 (this notice was followed by a November 22, 2013 written communication from the FDA).

We expect the Federal Register Notice of this upcoming panel meeting to occur in early January. The Panel meeting is subject to postponement or cancellation, at the agency's discretion, and subject to STAAR providing meeting-related documentation to the FDA pursuant to the FDA's schedule.

STAAR's President and Chief Executive Officer, Barry Caldwell, will give presentations to investors on December 3, 2013. A copy of the slide presentation Mr. Caldwell will use in his presentations is furnished as Exhibit 99.1 to this Report, and is incorporated herein by this reference.

The information furnished herewith pursuant to Item 7.01 of this Current Report, including Exhibit 99.1, shall not be deemed to be "filed" for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section. The information in Item 7.01 of this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.

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