Staar Surgical warning
This article was originally published in The Gray Sheet
Executive Summary
Staar hits another snag in its pursuit of approval for its toric implantable lens for astigmatism with the June 27 announcement of an FDA warning letter. The letter, disclosed in a filing with the U.S. Securities and Exchange Commission, resulted from a bioresearch monitoring inspection conducted from Feb. 15 through March 14 and what the agency characterized as inadequate responses to the inspector's written observations. FDA found fault with the firm's oversight of a clinical trial for the investigational Visian TICL phakic collamer lens, citing Staar for failing to ensure that certain clinical sites were covered by an investigational device exemption, among other concerns. The agency already pushed back the firm's expected product approval date last November when it asked for an amendment to Staar's April 2006 PMA supplement application, and again in February when it informed Staar that the product would require advisory panel review (1"The Gray Sheet" Feb. 12, 2007, In Brief)...