Class 1 Recall for CooperVision Contact Lenses

Brenda Goodman, MA

Disclosures

December 07, 2011

December 7, 2011 — The FDA has initiated a Class 1 recall for CooperVision Avaira Aquaform Sphere Soft Contact Lenses because they may cause blurry vision, eye pain, and injuries requiring medical treatment.

On November 19, 2011 CooperVision Inc. sent a recall notification letter to US distributors and health care practitioners covering 4.9 million Sphere lenses, which had already been shipped to customers around the world.

The problem appears to be the level of silicone oil left on the lenses during the manufacturing process, according to a company news release.

Recall Expanded

In August, the company recalled nearly 780,000 Avaira Toric lenses after the FDA received dozens of reports of eye pain and vision problems from wearers.

But the FDA felt that recall was too muted, and last month, the agency issued its own urgent warning about Avaira lenses and pressured CooperVision to step up its efforts to alert the public.

"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 at CooperVision, says in the release. "The health and safety of our customers is our top priority."

Customers who experience problems should remove the lenses immediately and contact their eye care provider.

People who are concerned that they may have received recalled lenses can check their lot numbers at www.coopervision.com/international-recall or through the free recall hotline, 1-855-526-6737.

Recalled lenses should be returned to the store where they were purchased or to the eye care provider who prescribed them.

SOURCES:

News release, CooperVision Inc., Nov. 17, 2011.

FDA MedWatch Safety Alert, CooperVision Avaira Soft Contact Lenses, posted Oct. 14, 2011.

FDA MedWatch Safety Alert, CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses, posted Dec. 7, 2011.

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