STAAR toric IOL receives CE mark

November 23, 2011

STAAR Surgical Co. has received CE mark approval for a single-piece toric IOL (nanoFLEX Toric Collamer Single Piece IOL). The IOL, which is designed for patients who have cataracts and astigmatism, was approved for correction of 1.0 D to 4.0 D of cylinder in 0.5-D steps.

Monrovia, CA-STAAR Surgical Co. has received CE mark approval for a single-piece toric IOL (nanoFLEX Toric Collamer Single Piece IOL). The implant, which is designed for patients who have cataracts and astigmatism, was approved for correction of 1.0 to 4.0 D of cylinder in 0.5-D steps.

First shipments of the IOL are scheduled for the first quarter of next year.

“Approval of [the device] in Europe is the first step in a process to establish the [single-piece toric IOL] globally as an improved option for cataract patients who also have astigmatism,” said Barry G. Caldwell, STARR Surgical president and chief executive officer. “We have also been in discussions with the FDA about the requirements to obtain approval of the [single-piece toric IOL] in the United States.”

According to STARR Surgical, approval of the cylinder range from 1.0 to 4.0 D allows the lens to correct vision in more than 95% of eyes with clinically significant astigmatism.

Collamer is a trademark for STAAR’s proprietary biocompatible collagen copolymer lens material.

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