CooperVision has removed about 600,000 Avaira Toric contact lenses from the market after a number of consumers experienced potentially serious eye damage, but the FDA is suggesting that the recall has been done too quietly and the agency may issue a warning to alert the public.
The CooperVision contact lens recall was issued in August for Avaira Toric contact lenses, which were sold at Costco, LensCrafters and Wal-Mart, among other retailers.
The recall was not widely publicized and it was done so secretively that the FDA has called for the company to issue a broader recall notification and explanation of the reported problems with the contact lenses.
CooperVision has, to date, ignored the FDA’s request to make the contact lens recall more public, so the FDA is now determining whether its own Avaira Toric safety warning is needed.
Reports from consumers include a wide variety of problems, from hazy vision to torn corneas, according to a report by MSNBC.com. One patient’s wife reported to the FDA that the contact lenses took chunks off of the surface of her husband’s eye when removed. Some users of the recalled contact lens have reportedly required treatment in an emergency room.
CooperVision issued the recall because of what it called an unidentified residue on the lenses. But the company did not issue a list of lots affected by the recall or details on the problem. The recall notice only mentions that some users have complained of “temporary hazy vision.” The manufacturer did not disclose that some users reported experiencing torn corneas and severe eye damage.
Production of the CooperVision contact lenses has been stopped so that the company can fix the problem. The manufacturer estimates that Avaira Toric contact lenses will be shipping in normal amounts again by December.
Contact lenses result in more children visiting the emergency room than any other type of medical device according to federal regulators. Most of those incidents are due to eye infections and abrasions because children wore them too long without cleaning them the FDA has found.