Staar Surgical
This article was originally published in The Gray Sheet
Executive Summary
FDA issues an "approvable" letter to Staar for its Myopic Visian ICL, pending an inspection of the company's manufacturing facilities, methods and controls. Staar, which has attempted to earn approval for the device since 2003, was stymied by warning letters in 2003 and 2004. Most recently, Staar responded to a July 15 FDA Form 483 letter listing quality systems violations at the firm's Monrovia, Calif. facilities (1"The Gray Sheet" July 18, 2005, p. 14)...