Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.
CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company's Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.
The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.
Dozens of Avaira Toric users reported problems ranging from hazy vision and pain to severe injuries, including torn corneas, which required emergency medical treatment. Company officials were accused of issuing a "stealth recall" in August that left many consumers unaware of the problem.
Company officials noted that no product lines other than Avaira Toric and Avaira Sphere use silicone oil to manufacture the products. The firm expects to set aside a reserve of $9 million for the costs of the expanded recall. All told, the company expects to spend $23.2 million on the Avaira recalls, according to the press release.
Consumers with problems or questions related to the recalls should contact the company at 1-855-526-6737. The firm says it has reached out to affected consumers to ensure their safety.