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STAAR receives CE mark for Collamer lens

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MONROVIA, Calif. — STAAR Surgical has received CE mark approval for a Collamer single-piece IOL, the company announced in a press release.

Made of collagen and a poly-HEMA-based copolymer, the nanoFLEX IOL can be injected through a 2.2-mm incision with STAAR's nanoPOINT injector system. The material has been proven to induce fewer higher-order aberrations and can reduce or eliminate glares and halos, the release said.

The lens also features the company's proprietary aspheric optic design, which is designed to work with the curved anatomy of the eye.

Clinical studies have shown the nanoFLEX IOL to provide good near, intermediate and distance vision, with visual outcomes comparable to those of premium IOLs, according to the release.

STAAR is currently working with the U.S. Food and Drug Administration to obtain clinical data to support additional product claims.

"The nanoFLEX approval to market in Europe is a very important milestone for STAAR Surgical," company CEO Barry G. Caldwell said in the release. "The increased demand can be met with our existing production capacity, and the higher volume should lower our unit production cost."