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AMO recalls contact lens care products
Santa Ana, CA-Advanced Medical Optics Inc. (AMO) has announced a voluntary recall of 18 lots of its 12-ounce Complete MoisturePLUS multipurpose contact lens care solution and Active Packs distributed in the United States, because of an issue on two of four production lines at its manufacturing plant in China, the company said.
Santa Ana, CA-Advanced Medical Optics Inc. (AMO) has announced a voluntary recall of 18 lots of its 12-ounce Complete MoisturePLUS multipurpose contact lens care solution and Active Packs distributed in the United States, because of an issue on two of four production lines at its manufacturing plant in China, the company said.
Three lots manufactured during the same production period and sold in Japan were found to have bacterial contamination that could lead to eye infection or microbial keratitis in users. AMO has not received any reports of adverse health events associated with the recalled product lots in the United States.
Product from the recalled lots was distributed nationwide to food, drug, and mass merchandisers. The Nov. 21 recall does not include 4- and 16-ounce bottles, or professional samples and packs provided to eye-care practitioners, nor does it include products manufactured in AMO’s facility in Spain, which makes most of the AMO contact lens solution products distributed in the United States and Europe.
“This is a production-line issue and is not related to our formulations, which have been used safely by contact lens wearers for years,” said Jim Mazzo, chairman, president, and chief executive officer of AMO. “While we believe the likelihood of patients experiencing an adverse reaction is low based on our investigation to date, we are implementing this voluntary recall as a precautionary measure. …We want to be abundantly certain that eye-care practitioners and their patients know they can continue to rely on and trust AMO for products that meet high quality standards. We are working aggressively to replace recalled product and minimize the inconvenience this action may cause.”
For a complete list of lot numbers, product descriptions, and bottled lot number(s) of kits for the recalled product lot, see www.amo-inc.com or www.fda.gov/oc/po/firmrecalls/advmedical11_06.html.
Patients reporting redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling related to their eyes should be advised to remove their contact lenses immediately and discontinue use of the product. Consumers possessing the recalled product should call 877/884-7779 Monday through Friday between 8 a.m. and 5 p.m. eastern time or visit www.amo-inc.com for instructions. Adverse reactions or quality problems related to the use of these products should be reported to AMO at 800/347-5005 and to the FDA’s MedWatch Program at (phone) 800/FDA-1088, (fax) 800/FDA-0178, (Web) www.fda.gov/medwatch, or (mail) MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company is contacting retailers, customers, and distributors regarding return and replacement instructions and will provide reply cards and mailing slips.
The U.S. recall includes approximately 183,000 units, representing less than 1% of Complete MoisturePLUS contact lens products annually distributed in the United States. AMO also conducted a limited product withdrawal in Japan and has temporarily ceased all manufacturing at the China facility, where manufacturing areas and applicable equipment will be cleaned and sanitized. Production there is expected to cease for 10 to 12 weeks, during which time the company will proceed with a previously planned expansion by adding new filling lines and increasing packaging capacity.
Company officials said they expect the recall to reduce AMO revenue for the remainder of 2006 and 2007 by $40 million to $45 million due to product returns, supply shortages, and temporary lost market share, primarily in Japan and Asia Pacific, where most of the products produced at the China facility are shipped. As a result, AMO now expects its 2006 revenue to be $985 million to $1 billion and its 2007 revenue to be $1.06 billion to $1.08 billion.
During this time, AMO officials also said they expect the company to incur charges and costs of $35 million to $40 million to complete the recall, remedy the manufacturing issue, and restore market share. Additionally, the company expects reductions in previously forecast adjusted earnings per share, adjusted growth margin, and adjusted operating margin.
