Staar Surgical gets CE Mark approval for cataracts product

By Elaine Rigoli

Tampa, Fla., May 4 - Staar Surgical Co. has received CE Mark approval for its preloaded aspheric silicone intraocular lens, which will enable the company to market the aspheric silicone lens for use in cataract surgery in 21 countries where the CE Mark is accepted.

The preloaded intraocular lenses are not yet approved for use in the United States.

The KS-3Ai is a preloaded intraocular lens that includes the lens, cartridge and injector body in a single, disposable pre-sterilized unit, offering ease, safety and convenience to the surgeon while providing a sterile pathway directly into the eye, the company said in a news release.

The refined aspheric lens is designed to be delivered through an incision size smaller than 3 mm, an important criterion for minimally invasive cataract surgery.

Preloaded silicone intraocular lenses have grown significantly in international markets and as of the first-quarter 2006, represented 18% of Staar's total intraocular lens sales, officials said.

Staar, based in Monrovia, Calif., develops minimally invasive ophthalmic products.

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