Advanced Medical Optics (AMO) has announced a voluntary and immediate recall of its COMPLETE® MoisturePLUS™ contact lens solution. The recall is being initiated because of concerns over eye infections from Acanthamoeba, a naturally occurring water-bourne organism which can contribute to serious corneal infections.

There is no evidence to suggest that today’s recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens care products, including our hydrogen peroxide disinfecting solutions.

The U.S. Centre for Disease Control and Prevention (CDC) made data available to AMO showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using COMPLETE® MoisturePLUSTM products. The CDC estimates a risk of at least seven times greater for those who used COMPLETE® MoisturePLUSTM solution versus those who did not. This recall is being conducted on a voluntary basis, in cooperation with the respective regulators.

The incidence of AK infections has been estimated by the CDC at approximately one to two cases per million contact lens wearers. Acanthamoeba is an organism commonly founding water, soil, sewage systems, cooling towers, and heating/air-conditioning systems. AK infections are usually found among individuals who improperly store/handle/disinfect their lenses (e.g. use tap water to clean lenses, swim or shower while wearing lenses or come in contact with contaminated water, especially is the corneal has been damaged)

Our first priority is protecting lens wearers’ vision and health. We remain fully committed to providing you with products that meet the highest standards for sterility, product effectiveness and customer safety. We are fully cooperating with the necessary regulatory authorities to meet these goals, and sincerely apologise for any inconvenience this action may have caused to you as a user of our products.

If you are a contact lens wearer and have any of these symptoms, you should consult your eye care professional: eye pain, eye redness, blurred vision, sensitivity to light, sensation of some thing in the eye, and excessive tearing. The symptoms, which can last several months, are not the same for everybody. Early in the infection, the symptoms of AK can be very similar to the symptoms of other more common eye infections but AK may eventually cause severe pain and possible vision loss with some people requiring a corneal transplant, if untreated.

While AMO believes the likelihood of users experiencing an adverse reaction is low, we have taken a conservative approach and are conducting the recall in the best interests of our customers

AMO has a 50 year heritage built on high safety and efficacy standards for our products. We are committed to protecting the trust Eyecare professionals and consumers place in our products and will take all necessary measures to ensure that our products remain safe and effective for daily disinfecting for all contact lenses.