Federal regulators have deemed CooperVision Inc.’s expanded Avaira Sphere contact lens recall a Class I recall, according to an announcement from the U.S. Food & Drug Administration (FDA). The expanded recall, which was announced on November 15, involved CooperVision’s Avaira Aquaform Comfort Science enfilcon A Daily Wear Sphere Soft Contact Lenses (Avaira Sphere).
The November 15 Avaira Sphere contact lens recall added more than 6 million lenses to the previously announced Avaira Toric contact lens recall. The earlier recall action was announced by CooperVision in August, and included 600,000 Avaira Toric lenses sold in the U.S. The FDA deemed the Avaira Toric recall a Class I recall in October.
Class I recalls are the most serious type of recall and involve situations in which the FDA has determined there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
CooperVision ordered the Avaira contact lens recalls due to the unintended presence of a silicone oil residue on the Toric and Sphere soft contact lenses. As of November 15, the FDA had received 40 reports of problems associated with various CooperVision contact lenses. Of those, at least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere.
Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. Some Avaira contact lens users have reportedly suffered from torn corneas and cornea abrasions.
Of the 6.6 million Avaira Sphere contact lenses included in the November 15 recall, about 4.9 million had already been shipped to customers globally.
When the original Avaira Toric CooperVision recall first came to light in October, the company was criticized for failing to issue a widespread warning to consumers. In August, CooperVision had only notified only U.S. and Canadian distributors and health care practitioners who sold the lenses, and some users complained they never heard about the recall prior to experiencing a problem. In October, however, the FDA pressured the company to widen its recall notification.
Users of both Avaira Toric and Avaira Sphere contact lenses have been advised to stop wearing them if they experience eye problems, and seek medical attention immediately. CooperVision has also set up a website for wearers to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Lens wearers can also contact CooperVision on a toll-free consumer hotline at 1-855-526-6737. Anyone with lenses included in the recall should return them to the point of purchase or to their eye care practitioner.