FDA recalls chemical agent used in eye surgery

Cornea transplant product linked to dozens of optical problems

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updated 10:50 a.m. ET Jan. 2, 2009

WASHINGTON - Federal regulators are calling on physicians to return a chemical agent made by Advanced Medical Optics Inc., saying it has been linked to dozens of eye problems.

The Food and Drug Administration issued a recall on lot number UD30654 of Healon D, a surgical agent used in cornea transplants, cataract removal and other ophthalmic procedures. The product comes prepackaged in a syringe and is applied using a small tube.

The FDA classified the recall as 'class I,' which means the product could "cause serious health problems or death."

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The Santa Ana, Calif.-based manufacturer already issued its own recall on the lots of Healon in late October. However, the company has only recovered 964 of the 1,450 units that were distributed on the market.

Advanced Medical Optics has received 66 reports of negative reactions with the product, including inflammation of the eye. Testing of the recalled product revealed elevated levels of endotoxin, which has been associated with eye problems.

The FDA urged customers to remove the products from inventory and contact the company at 1-877-AMO-4LIFE to arrange a return.

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