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Visian® ICL and Toric ICL V4c Receive CE Mark Approval
Date:4/25/2011

ual disturbances which proved to provide the same excellent results documented with the Visian ICL technology.  Dr. Shimizu has continued to use the technology in additional patients since completing his study.

"We appreciate very much the clinical work and advice of Dr. Shimizu and other leading Visian ICL surgeons, who were instrumental in bringing this very significant improvement to the market," said STAAR Surgical CEO Barry G.  Caldwell.  "This technology marks another key advancement from our product pipeline of planned new features designed to provide continuous enhancements to the Visian ICL technology.  Late last year we launched the V4b ICL model in CE Mark countries, which expanded the range of approved treatment zones on the myopic, hyperopic and Toric models of the ICL.  This added range of treatment has already resulted in increased usage of the product in those markets."

"We are off to a good start in 2011 with strong sales of the ICL products outside the U.S.," continued Mr. Caldwell.  "This CE Mark approval positions us to build further on this momentum this year.  In addition, the V5 model is currently underway with our Research and Development team and the concept designs for the V6 model are in the feasibility phase.  I would also like to thank and congratulate our R&D and Regulatory teams, which worked together to bring the V4c technology to market earlier than originally anticipated."

The V4c model has been approved in the -0.5 diopter to -18.0 diopters myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.  The Company plans to first engage a pre-market release of the product in four sites and 100 eyes before a full launch to the markets that accept CE Mark Approvals.  In some of the key Asia Pacific markets that have not yet launched the V4b model, the Company plans to seek approval of the V4c and move directly to this new model.

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