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AMO recalls potentially adulterated lenses in Brazil

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AMO has initiated a recall of 98 PhacoFlex II IOLs that “appear to have been adulterated accidentally,” according to Russ Trenary, corporate vice president and president/Americas. According to a Food and Drug Administration Enforcement Report, AMO sent three letters to notify physicians and distributors of the lenses in Brazil of the potential problem. The Enforcement Report notes AMO chose to recall the lenses because of “postoperative complaints of cloudiness in the IOL.”

“We just went after all the lenses that might have been affected,” Mr. Trenary told Ocular Surgery News. “We don’t know how many actually had a problem, but we believe a fraction of the total amount had either been implanted or on their way to an ophthalmologist.”

Mr. Trenary noted the company was “down to a handful” of lenses that had not yet been returned to AMO.