Voluntary Recall of Contact Lens Care Products

FDA, Nov 27, 2006

Voluntary Recall of Contact Lens Care Products

Advanced Medical Optics, Inc., a global ophthalmic surgical and eye care products company, announced a nationwide, voluntary recall of certain lots of its 12-ounce COMPLETE® MoisturePLUS(TM) multipurpose contact lens care solution and Active Packs. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at its manufacturing plant in China, AMO is recalling 18 lots distributed in the U.S. that were manufactured on the same production lines during the same production period. Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.

The U.S. recall includes approximately 183,000 units, representing less than one percent of COMPLETE® MoisturePLUS(TM) contact lens products distributed in the U.S. on an annual basis. Based on its investigation to date, AMO believes the likelihood of users experiencing an adverse reaction is low. However, the company is taking a conservative approach and is conducting the recall in the best interest of its customers.

The company commenced the investigation after testing of products sold in Japan determined that three production lots were found to be non-sterile and contaminated with bacteria. As a result, AMO conducted a limited product withdrawal in Japan and notified appropriate global regulatory authorities, including the FDA. The subsequent investigation traced the manufacturing issue to two of the four production lines in its China facility that manufactured product during a specific period. This product was shipped to the U.S., Japan and Asia Pacific and is now the subject of this recall. AMO has temporarily ceased all manufacturing at the China facility and scheduled a special cleaning and sanitation of the manufacturing areas and all applicable equipment.

Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.