Contact Lens Solution Infections Reported One Year Before AMO Recall

Recently uncovered documents reveal that Advanced Medical Optics (AMO) had evidence that severe contact lens solution infections were associated with the use of their Complete MoisturePLUS product more than one year before they removed the solution from the market.

The documents surfaced as part of on-going lawsuits against AMO in connection with a 2007 outbreak of Acanthamoeba keratitis eye infections that led to a Complete MoisturePlus recall on May 26, 2007.

According to a report by the Associated Press, AMO received at least nine reports of customers who contracted Acanthamoeba keratitis starting as early as February 2006. However, the company did not turn those reports over to the FDA and continued to sell their multipurpose contact lens cleaner without taking steps to protect the public. The reports were not turned over to the FDA until after the recall was issued, when the agency started an investigation.

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More than 100 people have filed an Acanthamoeba keratitis eye infection lawsuit against AMO, alleging that that they suffered severe injuries to their eyes and vision as a result of the Complete MoisturePlus solution. The contact lens solution infections caused at least three people to have an eye removed, three others went blind and more than 20 received corneal transplants.

Acanthamoeba keratitis is caused by a micro-organism that inhabits water, soil, sewage, cooling towers and heating and air conditioning systems. Traditionally, it is often associated with improper cleaning of contact lenses or with wearers who use their contact lenses in humid, wet conditions, such as a pool or shower. However, following the recall, the U.S. Centers for Disease Control and Prevention (CDC) indicated that users of Complete MoisturePlus were at least seven times more likely to develop the eye infection

In addition to failing to turn over to the FDA the reports of users who suffered the severe eye infections, AMO has been sharply criticized for their handling of the recall. The CDC reported that two months after the recall was issued, millions of bottles of the contact lens solution remained in homes and a field report found that less than half of all contact lens wearers interviewed were aware that there had been a recall and less than a quarter knew which product was impacted.

Last week, the FDA issued an advisory to update consumers on the proper care and treatment of contact lenses to help prevent future infections. The guidance came about as the result of an FDA contact lens workshop held earlier this year.

FDA researchers found that a rub-and-rinse regime resulted in a significant improvement in lens cleaning than rinsing alone. The new guidance makes recommendations that all contact lens solution manufacturers include rubbing lenses with the solution as part of the cleaning process.

AMO Complete MoisturePlus was considered part of the no-rub brands of contact lens solutions that were used to store, clean and re-wet contact lenses.

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