Staar Surgical Co. (NASDAQ:STAA) landed CE Mark approval in the European Union for its nanoFLEX Toric IOL for use in cataract patients with astigmatism.
First shipments of the nanoFLEX intraocular lens are scheduled to roll out to the European market in the first quarter of 2012.
“Approval in Europe is the first step in a process to establish the nanoFLEX Toric IOL globally as an improved option for cataract patients who also have astigmatism," said Barry Caldwell, Staar’s president & CEO in prepared remarks.
Staar has been in talks with the FDA about opening nanoFLEX to the U.S. Market, according to the company.
The refractive lens-maker received word from Japan’s Pharmaceuticals and Medical Device Agency last month that its Toric implantable collamer lens will not need to go before the approval committee.
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