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.