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Approval in 2007 not likely for Visian toric ICL, says STAAR

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MONROVIA, Calif. — The U.S. Food and Drug Administration has ruled that a toric version of the approved Visian ICL must undergo a full review by the Ophthalmic Device Panel of the Center for Devices and Radiological Health. Approval of the lens is no longer expected in 2007, according to a press release from STAAR Surgical, the device's manufacturer.

In April 2006, STAAR submitted the toric ICL (TICL) application as a supplement to its pre-market approval application for the myopic version of the lens, which was approved in December 2005. The FDA requested a full review of the supplemental application because "the TICL is the first toric phakic implantable lens to be reviewed," according to the release.

In November, the FDA requested additional data on transitory rises in the rate of excessive ICL vaulting that STAAR reported last year. The current decision arose from STAAR's meeting with the FDA to discuss those concerns.

The Visian TICL is already approved and marketed in Europe and some Asian nations, according to the release.