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Advanced Medical Optics (AMO) voluntarily recalled a single lot of its ophthalmic viscosurgical device ([OVD] Healon D) after physicians noticed inflammation at some patients' 1-day postoperative visit.
Santa Ana, CA-Advanced Medical Optics (AMO) voluntarily recalled a single lot of its ophthalmic viscosurgical device ([OVD] Healon D) after physicians noticed inflammation at some patients' 1-day postoperative visit.
The lot, with a product code of 10204011 and lot number UD30654, was recalled because endotoxin levels exceeded product guidelines in some syringes, according to an Oct. 30 letter that Sandra Selvaggi, AMO's vice president for global quality assurance and compliance, sent to customers. Elevated endotoxin levels could cause an inflammatory response or toxic anterior segment syndrome in patients following surgery, Selvaggi said.
The recall did not affect any other OVD products from the company, and AMO will report the recall to the FDA, Selvaggi said in the letter. The product has been available in Europe since July.
This is the first recall associated with the product, said Steve Chesterman, AMO manager, global corporate communications. He said the company does not release specific information about adverse events and could not comment on how many patients were affected by the recall.
"However, we initiated the voluntary recall shortly after the lot was distributed in the United States, so only a limited amount of product was sold to customers," he said. "We initiated the voluntary recall immediately after learning of a limited number of adverse events.
"Because it was a limited distribution, we have been very successful in quickly retrieving the product," Chesterman said. "In fact, all product from the recalled lot is either already in our control or being shipped back to us."
Ophthalmologists are asked to contact AMO customer service at 877/266-4543 to arrange return of the product.