ALERT - RECALL
Complete® MoisturePLUS™
Complete® MoisturePLUS™ is an “all-in-one” multi-purpose contact lens solution that is used to clean soft contact lenses. This product is manufactured by Advanced Medical Optics, Inc.
Advanced Medical Optics Inc. (AMO) engages in the development, manufacture, and marketing of medical devices, including multipurpose lens care products for the eyes. AMO is based in Santa Ana, California. Its product, Complete® MoisturePLUS™, comprised approximately 10% of the contact lens solution marketed in the U.S.
Complete® MoisturePLUS™ has been found to cause acanthamoeba keratitis (AK), a potentially blinding eye infection.
Acanthamoeba is a naturally occurring mico-organism that is found in common substances such as water and soil. It is also found in heating and air conditioning units.
Acanthamoeba keratitis (AK) is a rare, but serious infection of the cornea. It is difficult to treat, and can result in permanent visual impairment or blindness. In the U.S., more than 80% of all cases of this infection involve soft contact lens users who are otherwise in good health. Generally, AK occurs in about one or two out of every one million contact lens wearers, including those who fail to properly clean their lenses after using a swimming pool, hot tub or shower.
On May 26, 2007, Advanced Medical Optics recalled Complete® MoisturePLUS™ from the market. The Centers for Disease Control and Prevention (CDC) has received reports of 138 confirmed cases of acanthamoeba keratitis in people who have used Complete® MoisturePLUS™. Moreover, the CDC estimates that the risk for developing acanthamoeba keratitis is at least seven times greater for persons who have used Complete® MoisturePLUS™, as compared to other solutions.
Estimates show that this represents a 700% increase in risk of severe eye infections (AK) for those who used Complete® MoisturePLUS™ as opposed to those who did not. |