Advanced Medical Optics Inc. is recalling 2.9 million packets of its Complete MoisturePlus multipurpose contact-lens solution and Active Packs, after it found bacterial contamination in three lots sold in Japan.
The recall includes 183,000 units sold in the U.S.
The company, based in Santa Ana, Calif., blamed the the contamination on a water-borne organism that got into some solution at the company's plant in China. The plant has been shut down until the problem can be resolved, the company said. Advanced Medical said there is no problem with the lens solution's formula.
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.
Consumer should 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 contact lens products distributed in the U.S. on an annual basis. Based on its investigation to date, AMO said it believes the likelihood of users experiencing an adverse reaction is low. However, the company said it is taking a conservative approach and is conducting the recall in the best interest of its customers.
A complete list of lot numbers of the recalled units is available on the company's Web site
Earlier this year, Bausch & Lomb withdrew its ReNu with MoistureLoc after weeks of evasive and sometimes misleading attempts to deflect responsibility. The solution was implicated in seveeral cases of a serious eye infection, Fusarium keratitis.
