AAFES RECALL NO. 06-046
RELEASE DATE: 22 November 2006
SUBJECT: HAZARDOUS RECALL - Advanced Medical Optics recalls Complete MoisturePlus Contact Lens Solutions (12 oz)DISTRIBUTION: WORLDWIDE (Distribution was made to stores serviced by DDDC) Advanced Medical Optics (AMO), in cooperation with FDA, is voluntarily recalling 18 lots of Complete MoisturePLUS multipurpose contact lens care solution (12 oz.)for bacterial contamination.
HAZARD: Non-sterility of a contact lens solution may have serious health consequences, including eye infection and microbial keratitis. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Only 18 lots (183000 Units) distributed in the U.S. were also manufactured at same plant and production line during the same period in China. AMO has not received any reports of adverse health events associated with the recalled product lots in the U.S.
DESCRIPTION: Complete MoisturePLUS multipurpose contact lens care solution (12 oz.), UPC # 827444-00001 AMO Code#: 90104US
Batch #s:
ZB02718 & ZB02722. The Lot numbers are located on the top of the packaging box and on the side of the bottle.Made In:
Only products Made in China are affected. Most of the product distributed in USA & Europe was Made in Spain, which is not affected.INSTRUCTIONS FOR CUSTOMERS: 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 have 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.
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. The details of the recalled lots are at the FDA’s link: http://www.fda.gov/oc/po/firmrecalls/advmedical11_06.html
Home | History | About AAFES | Store Locator
Contact AAFES | Employment | AAFES Sale Flyers | Online Shopping