Lens Recall Spurs Cooper Class Action Suit, Focus on Poor Quality Controls

Cooper Companies failed to warn stockholders about quality problems leading up to its massive recall of Avaira Toric and Sphere lenses, and is now facing a class action lawsuit.

According to the complaint, Cooper and its officers and directors violated the law by misleading investors about the state of the company’s quality controls, manufacturing processes and other business fundamentals, leading to inflated stock prices.

Cooper voluntarily recalled 6.6 million CooperVision contact lenses between August and November because of silicone oil residue that could cause blurry vision, severe eye injury or loss of vision.

About 93 percent of FDA device warning letters fall into 5 categories: risk management, design control, supplier quality, QSR compliance and postmarket surveillance. We call them the “big five.”

If you need help addressing your big five woes, register today for the Ninth Annual Medical Device Quality Congress this May 16–18. This is one event you can’t afford to miss.