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AMO recalling 2.9 million units of Complete MoisturePlus contact lens solution
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SANTA ANA, Calif. — Advanced Medical Optics Inc. is voluntarily recalling 2.9 million units of its Complete MoisturePlus multipurpose contact lens solution in the United States, Japan and the Asia-Pacific region due to the possibility of bacterial contamination, the company announced.
The company initiated the recall after three lots of the product, sold in Japan, were found to be nonsterile and contaminated with bacteria. The contamination may have been due to a production line problem at AMO's Chinese manufacturing plant, according to a press release from AMO.
The recall involves 18 lots, or 183,000 units, distributed in the United States that were manufactured on the same production line as the contaminated Japanese units, according to the press release.
AMO has not received any reports of adverse events in the U.S., and the company considers the likelihood of adverse reactions low, but it is conducting the recall "in the best interest of its consumers," company officials noted in the release.
Most of AMO's lens care products distributed in the United States and Europe are manufactured at a facility in Spain and are not affected by the recall.
The recall includes certain lots of 12-oz bottles and Active Packs, and it amounts to less than 1% of the product distributed within the U.S. annually, according to the company. The recall does not include 4-oz and 16-oz bottles, professional samples or packs provided to eye care professionals, the release said.
The company said it has closed the manufacturing plant in China for special cleaning and sanitization, which is expected to take 10 to 12 weeks.
As a result of the recall, AMO has lowered its 2006 revenue estimates to a range of $985 million to $1 billion, compared to previous guidance of $1.01 billion to $1.02 billion. For 2007, AMO now expects revenue to range from $1.06 billion to $1.08 billion, compared to previous guidance of $1.08 billion to $1.1 billion, according to a separate AMO press release.
A complete list of product names and lot numbers being recalled is available on the Web site of the U.S. Food and Drug Administration, here. Lot numbers are located on the top of the product box and on the side of the product bottle, according to the AMO press release.