Recall -- Firm Press Release
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Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete(R) MoisturePLUS(TM) Contact Lens Care Products Distributed and Sold in the U.S.
Includes Certain Lots of 12-Ounce Bottles and Active Packs
Deborah Kazenelson Deane
FOR IMMEDIATE RELEASE -- Santa Ana, CA -- November 21, 2006 -- Advanced Medical Optics, Inc., a global ophthalmic surgical and eye care products company, today 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.
Lot numbers are located on the top of the product box and on the side of the product bottle. The recalled product lots include:
|Package Lot No.||Product Description||Bottled Lot Number(s) in Kit|
|ZB03087||COMPLETE MoisturePLUS Active Pack||ZB03085, ZB02845|
|ZB03724||COMPLETE MoisturePLUS Active Pack||ZB03713, ZB03506|
|ZB03734||COMPLETE MoisturePLUS Active Pack||ZB03713, ZB03506|
|ZB03735||COMPLETE MoisturePLUS Active Pack||ZB03713, ZB03510|
|ZB03736||COMPLETE MoisturePLUS Active Pack||ZB03713, ZB03510|
|ZB03739||COMPLETE MoisturePLUS Active Pack||ZB03737, ZB03510|
|ZB02710||COMPLETE MoisturePLUS 12oz (360 mL)||ZB02709|
|ZB02714||COMPLETE MoisturePLUS 12oz (360 mL)||ZB02713|
|ZB02718||COMPLETE MoisturePLUS 12oz (360 mL)||ZB02717|
|ZB02722||COMPLETE MoisturePLUS 12oz (360 mL)||ZB02721|
|ZB02746||COMPLTE MoisturePLUS 2 X 12 oz||ZB02745|
|ZB02750||COMPLETE MoisturePLUS 2 X 12 oz||ZB02749|
|ZB02771||COMPLETE MoisturePLUS 2 X 12 oz||ZB02770|
|ZB02792||COMPLETE MoisturePLUS 2 X 12 oz||ZB02791|
|ZB02796||COMPLETE MoisturePLUS 2 X 12 oz||ZB02795|
|ZB02800||COMPLETE MoisturePLUS 2 X 12 oz||ZB02799|
|ZB02804||COMPLETE MoisturePLUS 2 X 12 oz||ZB02803|
|ZB03535||COMPLETE MoisturePLUS 2 X 12 oz||ZB03534|
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.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-877-884-7779 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time or visit www.amo-inc.com for instructions. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-877-884-7779 Monday through Friday from 8 a.m. through 5 p.m. Eastern Time for more information.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005 and to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Product from the recalled lots was distributed nationwide to food, drug and mass merchandiser accounts. The recall does not include 4-ounce and 16-ounce bottles, or professional samples and packs provided to eye care practitioners.
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.
Products manufactured in AMO's facility in Spain, which produces the vast majority of AMO's contact lens solution products distributed in the U.S. and Europe, 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," said Randy Meier, executive vice president, operations; president, global eye care and chief financial officer. "COMPLETE® MoisturePLUS(TM) products have been used safely by millions of contact lens wearers since their introduction in 2003 and are supported by our 50-year heritage of meeting high safety and efficacy standards."