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FDA review date set for phakic IOL (intraocular lens):

This article was originally published in Clinica

Executive Summary

The US FDA has said it will review Ophtec USA and Advance Medical Optics' PMA submission for their phakic intraocular lens (IOL) on February 5, 2004. Already available in Europe, the Verisyse lens was granted expedited review status last August. It is aimed at the correction of nearsightedness in the range of -5 to -20 dioptres. The lens attaches to the periphery of the iris, without inhibiting the muscle's function. Santa Clara, California-based AMO is the distributor of the product in America and Japan, whilst Boca Raton, Florida firm Ophtec markets it in the rest of the world under the brand name Artisan.

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