On Tuesday, the U.S Food and Drug Administration announced a voluntary recall by Advanced Medical Optics Inc. (AMO) of nearly 3 million units of its 12-ounce Complete MoisturePLUS contact-lens solution and Complete MoisturePLUS Active Packs because of bacterial-contamination fears. The large majority of the potentially tainted units were shipped to Asia, but more than 180,000 units are being recalled in the United States.

According to the release posted by the FDA, “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.”

In addition, the FDA and AOM recommend that “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.”

To this point, California-based AMO has not received any domestic reports of health issues related to its product and they also said that their four-ounce and 16-ounce bottles were not subject to the recall. Any consumers who may be in possession of a product from one of the affected lots should refrain from using the product immediately. The company “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.”

Click to find the complete list of recalled domestic lots.

This is the second major recall of contact-lens solution this year. On May 15, Bausch & Lomb instigated a worldwide recall of its ReNu with MoistureLoc lens solution due to fears of keratitis.

This entry was posted on Wednesday, November 22nd, 2006 at 3:08 pm and is filed under Health Concerns, Legal News.