Problems with silicon oil residue have led to an expanded recall of Avaira contact lenses, adding millions of Avaira Sphere contacts to an earlier recall issued amid reports that consumers were suffering eye problems ranging from hazy vision to torn corneas.
The Avaira contact lens recall expansion was announced by CooperVision, Inc. on Tuesday, involving about 5 million Avaira Sphere contact lenses.
An original recall was issued in August, but last month the FDA classified it as a Class 1 medical device recall; a classification reserved for defective devices that the FDA believes are likely to cause serious injury or death. That recall affected more than 778,000 Avaira Toric contact lenses, but the FDA criticized CooperVision for failing to take sufficient steps to make sure consumers were aware of the problems and the recall.
The FDA has reportedly received at least 40 consumer complaints about the contact lenses, including at least two specifically involving Avaira Sphere lenses. CooperVision officials say they plan to set aside about $23 million to pay costs associated with the recall, with $9 million of that to designated to cover costs associated with the expansion.
Production of the CooperVision contact lenses has been stopped so that the company can fix problems that may be allowing silicon oil to contaminated the lenses. The manufacturer estimates that Avaira Toric contact lenses will be shipping in normal amounts again by December.
CooperVision has not released a complete list of lot numbers affected by the recall. Consumers who suspect they have lenses affected by the recall can visit the CooperVision recall announcement and enter the package lot number to see if their lenses are included.