Acanthamoeba keratitis a potentially blinding eye infection caused scrambling doctors and health officials this weekend to try and find out the reason for the outbreak which resembles a similar one that took place last year. Complete MoisturePlus manufactured by Advanced Medical Optics (AMO) has been pulled from store shelves as a result of the outbreak. The product markets itself as the “The first and only multi-purpose solution that contains two-tear like moisturizers, beneficial electrolytes and taurine.”

The Centers for Disease Control and Prevention (CDC), in concert with the Food and Drug Administration, state and other partners, has identified the outbreak called Acanthamoeba keratitis (AK). This infection is caused by a free-living ameba (Acanthamoeba) which is a microscopic organism found everywhere in nature. Infections can result in permanent visual impairment or blindness. AK primarily affects otherwise healthy people, most of whom wear contact lenses. In the United States, an estimated 85% of cases of this infection occur in contact lens users. The incidence of the disease in the U.S. is approximately one to two cases per million contact lens users.

CDC has received reports of 138 cases of culture-confirmed AK in 35 states and Puerto Rico. Thirty-nine of the 46 case-patients wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that, among soft contact lens users who reported the use of any type of solution, 21 (58%) reported having used Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution in the month prior to symptom onset. Out of the 37 case-patients for whom clinical data was available, 9 (24%) failed medical therapy and required or are expected to undergo corneal transplantation.

People who wear soft contact lenses and who use Advanced Medical Optics (AMO) CompleteR MoisturePlusTM Multi-Purpose Solution are advised to:

• Stop using the product immediately and discard all remaining solution including partially used or unopened bottles. Choose an alternative contact lens solution.
• Discard current lens storage container.
• Discard current pair of soft lenses.
• See a health care provider if experiencing any signs of eye infection: Eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing.

Acanthamoeba keratitis is caused by a parasite, can be difficult to detect and is hard to treat. This outbreak has involved at least 138 patients.

The outbreak last year was linked to a different manufacturer’s lens solution and a different microbe. In both instances, the cornea, the eye’s transparent outer covering, is at risk. But why two different microbes caused the outbreaks is not known at this time.

Last year, the outbreak of fusarium keratitis was caused by a fungus; there were 164 confirmed cases. It was linked to ReNu With MoistureLoc made by Bausch & Lomb, but how the product caused the problem is unknown.

AMO said they are pulling their product and that there was no evidence to suggest that its product was contaminated with acanthamoeba.

This entry was posted on Tuesday, May 29th, 2007 at 10:35 am and is filed under Defective Products, Health Concerns, Legal News, Product Recalls.