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Advanced Medical Optics Complete MoisturePLUS Recall

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Link to Article: Advanced Medical Optics Complete MoisturePLUS Recall

Posted in: Complete MoisturePLUS

Source | U.S. Food & Drug Administration

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

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.

What You Can Do & How We Can Help

If you or a loved one have used Complete MoisturePLUS and developed a serious side effect like microbial keratitis or corneal infection, you should contact us immediately. You may be entitled to compensation and we can help.

 

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