MONROVIA, Calif.--Staar Surgical
(Nasdaq: STAA) said the U.S. Food and Drug Administration has
reviewed its pre-market approval application for the Staar Myopic
Visian ICL and has determined that the application is approvable
“subject to an FDA inspection that finds the company’s
manufacturing facilities, methods and controls in compliance with
the applicable requirements of the FDA’s quality system
regulation.”
The ICL is a refractive phakic implant intended for placement in
the posterior chamber of the eye. The models of the Staar Myopic
Visian ICL subject to the pre-market approval are indicated for the
correction of myopia in adults.
August 2005
Latest News