AMO recalls Complete MoisturePlus lens solution
NEW YORK (Reuters) - Advanced Medical Optics Inc. EYE.N said late on Friday that it was recalling its Complete MoisturePlus contact lens solutions and called on consumers to stop using them after data showed a higher risk of eye infections.
The announcement follows ANO's recall of the same product last year due to a bacterial contamination, and a recall by rival Bausch & Lomb Inc. BOL.N after its contact lens solution was linked to infections.
The U.S. Centers for Disease Control and Prevention (CDC) interviewed 46 patients with Acanthamoeba keratitis, a rare but serious cornea infection, and found that of the 39 who wore soft contact lenses, 21 used Complete MoisturePlus.
The CDC estimated that risk of infection was at least seven times greater among users of the Complete MoisturePlus solution compared with those who were not , the company said.
"As patient safety is paramount to AMO, the company is taking decisive action to stop shipments, recall product from the marketplace, and encourage consumers to discontinue the use of AMO Complete MoisturePlus until further information is available," the company said in a statement.
AMO said there was no evidence to suggest that the recall is related to a product contamination issue. It also said it was cooperating with the CDC and the U.S. Food and Drug Administration to assess the data.
The company did not give an outlook for the expected financial impact of recalling the product, one of its top selling items. Last November, it recalled almost 3 million units of the Complete MoisturePlus solution due to sterility problems and lowered its earnings forecast.
AMO shares, which closed on Friday at $40.20, fell in after-hours trade and were last quoted at around $37.
Bausch & Lomb recalled its ReNu with MoistureLoc lens solution last year after it was linked to keratitis.
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