On November 21, Advanced Medical Optics (AMO) announced a nationwide, voluntary recall of 18 lots (2.9 million units) of its 12oz. Complete MoisturePLUS multipurpose solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination.
The problem stems from a production-line issue at its manufacturing plant in China, AMO says, so the company has recalled products manufactured on the same production lines during the same time.
Based on its investigation so far, the likelihood of users experiencing an adverse reaction is low, but the recall takes the conservative approach and is in the best interest of its customers, AMO says. The company has not received any reports of adverse health events associated with the recalled product lots in the United States.
Meanwhile, the company has temporarily ceased all manufacturing at the China facility and scheduled a special cleaning and sanitation of the manufacturing areas and all applicable equipment.
Products manufactured in AMOs facility in Spainwhich produces the large majority of AMOs contact lens solution products distributed in the U.S.are not affected by this recall.
AMO is committed to taking all necessary measures to remedy this production-line issue and protect the trust physicians and patients place in our products, says Randy Meier, executive vice president, operations; president, global eye care, and chief financial officer.For details on specific product lots, go to www.amo-inc.com.