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Published: Wednesday, 10/12/2011

Under pressure from FDA, CooperVision steps up recall of 600,000 contact lenses linked to pain

BY MATTHEW PERRONE
AP HEALTH WRITER

WASHINGTON — One of the nation's largest eye care companies is stepping up efforts to publicize its recall of more than a half-million contact lenses after coming under pressure from federal health regulators.

CooperVision issued its second announcement in two months about the recall of 600,000 Avaira Toric contact lenses linked to pain, red eye and blurred vision by wearers. The company first announced the recall Aug. 19 and said it had focused its efforts on more than 7,000 eye care professionals who sell the lenses.

But the Food and Drug Administration said Tuesday a larger effort was needed to alert consumers to the defective products, which contain a residue caused by a manufacturing problem.

"Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses," said agency spokeswoman Morgan Liscinsky, in a statement.

The increasingly public back-and-forth between Pleasanton, Calif., CooperVision and the FDA underscores the government's limited authority to dictate the handling of recalls.

The FDA generally negotiates the terms of product recalls with companies, though the agency cannot order a company to recall a product or dictate the terms of the plan. Earlier this year the FDA gained the power to order recalls of unsafe food as part of a federal overhaul of the U.S. food safety system. Consumer advocates and some lawmakers have long supported giving FDA the same power to order recalls of drugs and medical products, though efforts have never passed Congress.

The FDA didn't immediately respond to a request for comment on CooperVision's announcement Wednesday morning.

CooperVision said it "has fully cooperated with the FDA and continues to closely monitor the situation." Reports of hazy vision and discomfort have continued since the company first announced the recall. More than 8 million lenses are affected by the problems, according to the FDA, though only 600,000 made it onto the U.S. market.

Shares of the Cooper Companies Inc. rose $2.27, or 3.15 percent, in trading Wednesday after a Wells Fargo analyst said the financial impact of the recall would be small. The company's stock fell 8 percent in trading the previous day.

Wells Fargo's Larry Biegelsen said in a note that Avaira Toric lenses made up 1 percent of the company's sales last year, adding that the company is not aware of any permanent eye or vision damage linked to the products.

CooperVision previously set aside $14 million to pay for the recall. The company plans to relaunch the lenses later this year after the FDA signs off on manufacturing changes.



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