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