Contact Lens Solution Recall

Nov. 22, 2006 -- About 183,000 packages of 12-ounce Complete MoisturePLUS multipurpose contact lens solution and Complete MoisturePLUS Active Packs are being recalled due to possible bacterial contamination.

The FDA and Advanced Medical Optics (AMO), which makes the recalled products, say contact lens wearers should stop using the recalled products immediately.

People should remove their contacts and talk to an eye care specialist immediately if they experience eye infection symptoms such as redness, pain, tearing, increased sensitivity to light, blurry vision, discharge, or swelling, say the FDA and Advanced Medical Optics.

The recall only applies to 18 lots of the products, listed below.

"The vast majority" of Advanced Medical Optics' contact lens solution products distributed in the U.S. and Europe "are not affected by this recall," the company says.

Nonsterile contact lens solutions "may have serious health consequences, including eye infection," Advanced Medical Optics says in a news release that is posted on the FDA web site.

The company says it hasn't received any reports of health problems associated with the recalled product lots in the U.S.

Production Problem

The company blames production problems at a manufacturing plant in China for the problem.

Three lots of products made at that plant and sold in Japan were found to contain bacteria, the company says.

In light of that discovery, 18 lots of the products made at the Chinese plant and distributed in the U.S. are being recalled.

It doesn't affect 4-ounce or 16-ounce bottles, or samples and packs provided to eye-care professionals.

Recalled Products

Here is a chart from Advanced Medical Optics showing the recalled products.

Lot numbers can be found on the top of the product box and the side of the bottle.

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 COMPLETE 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

Report Problems

Advanced Medical Optics asks those who think they have the recalled products to stop using them immediately and call the company at 877-884-7779, Monday through Friday, between 8 a.m. and 5 p.m. Eastern time -- or visit the company's web site, www.amo-inc.com, for instructions.

Any adverse reactions to the products should be reported to the FDA's MedWatch program, which can be reached by phone at 800-FDA-1088 (800-332-1088), by fax at 800-FDA-0178 (800-332-0178), and online at www.fda.gov/medwatch.

Reports can also be mailed to the FDA at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Adverse reactions should also be reported to Advanced Medical Optics at 800-347-5005.

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SOURCES: News release, FDA. News release, Advance Medical Optics.