CooperVision expands contact lens recall

PLEASANTON, Calif. — CooperVision has expanded its worldwide recall of Avaira brand products to include a limited number of lots of Avaira Sphere contact lenses. The affected lenses did not meet updated quality requirements because of the level of silicone oil residue, which may cause hazy vision, discomfort, severe eye pain or eye injuries requiring medical treatment, according to a company press release.

"The company is confident we found the problem and have taken corrective action to fix the problem," Christine Moench, vice president of global regulatory affairs and quality assurance for CooperVision, said in the release. "The health and safety of our customers is our top priority."

The company is urging patients who use Avaira Sphere contact lenses and experience any symptoms to stop wearing the lenses immediately and contact their eye care practitioner for advice.

Patients can determine whether their lenses have been recalled by visiting the Avaira Sphere recall site (www.coopervision.com/international-recall) and entering the package lot number found on the lens carton or blister label. Lenses that are among the recalled lots should be returned to the point of purchase or to an eye care practitioner.

Patients can reach the CooperVision toll-free consumer hotline at 1-855-526-6737, according to the release.

Adverse events related to use of the lenses can be reported to the U.S. Food and Drug Administration's MedWatch Adverse Event Reporting program either online (www.fda.gov/MedWatch/report.htm), by fax (1-800-FDA-0178) or by regular mail using a postage-paid, pre-addressed Form FDA 3500, available at www.fda.gov/MedWatch/getforms.htm.