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Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume
Date:7/21/2009

MONROVIA, Calif., July 21 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) Division of Bioresearch Monitoring that the restrictions of the "integrity hold" put in place by the FDA on August 3, 2007 have been removed. The removal of the integrity hold enables the FDA to resume scientific review of the STAAR application for the Toric Implantable Collamer Lens (TICL(TM)) for Myopic/Astigmatic patients. This application is a PMA Supplement to the Visian ICL which the FDA approved on December 22, 2005.

"We are very pleased by the FDA's decision to remove the integrity hold. This very important step in the process is not to be construed as approval of any conditions that may be found in the future, nor should it be construed as clearance to market the Visian Toric ICL," stated Barry G. Caldwell, President &Chief Executive Officer of STAAR Surgical. "The removal does require that any supplement related to the Visian Toric ICL be audited and contain a certification from an independent third party auditor that all data in submission is complete, accurate and reliable. This same standard will be applied to the next subsequent submission for a 510(k), IDE or PMA sent to the FDA by the Company. We believe the outstanding clinical results with this technology are evidenced by the Visian Toric ICL's data. Additional evidence is the acceptance of the technology as more than 150,000 Visian ICLs have been implanted worldwide, of which more than 27,000 have been Visian Toric ICLs outside the U.S. The Visian Toric ICL corrects both myopia and astigmatism with the same procedure," added Mr. Caldwell.


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