Lawsuit Claims Eye Infections and Lost Vision Caused by Complete MoisturePlus Contact Lens Solution

Complete MoisturePlus contact lens solution is a product of Advanced Medical Optics, Inc. (AMO), an ophthalmic surgical and eye care products company. According to a Dec. 1 press release, the lens solution was recalled by AMO in May 2007, after the Centers for Disease Control and Prevention (CDC) determined that more than 135 people had developed a serious eye infection after using the solution. It was estimated at that time that perhaps half of these individuals may eventually need cornea transplants.

A California law firm has now filed a lawsuit against AMO on behalf of three women who suffered eye damage and vision loss as a result of contracting Acanthamoeba keratitis after using Complete MoisturePlus.

According to the CDC, Acanthamoeba is a microscopic ameba that's commonly found in the environment, such as swimming pools and hot tubs, sewage and drinking water systems, shower heads and the soil. Most people will at some time in their lives be exposed to Acanthamoeba, but will not show symptoms or become ill. Acanthamoeba keratitis, on the other hand, is a localized infection of the eye that can result in permanent visual impairment, blindness and the need of a cornea transplant for some. Those who've been affected are contact lens wearers and otherwise healthy.

One of the three women in the lawsuit who'd used AMO's Complete MoisturePlus was diagnosed with Acanthamoeba keratitis in January 2007. She claims she has suffered permanent corneal scarring as a result of the infection and may need a cornea transplant to repair the damage. Reportedly, her doctor says that even with corrective lenses, she'll never regain normal vision as a result of the scars on her cornea.

The timing of the woman's diagnosis is significant in that AMO is alleged to have been aware of a possible link between its product and Acanthamoeba keratitis since 2004, but did not make a full recall of Complete MoisturePlus until May 2007.

A May 26, 2007, CDC report says that a year earlier, in May 2006, the Illinois Dept. of Public Health notified the CDC of a possible increase in Acanthamoeba keratitis at an ophthamology center in the state during the preceding three years. After an investigation, it was confirmed that there was in fact an increase in cases of Acanthamoeba keratitis, and the increase had begun in 2004. It was also determined that the increase in infections occurred in soft contact lens wearers who used AMO's Complete MoisturePlus multipurpose cleaning solution. In May 2007, AMO recalled their product.

However, the lawsuit alleges that AMO continued to sell and market Complete MoisturePlus through May 2007, despite being aware of the 2004 link between their product and Acanthamoeba keratitis infections. AMO of course denies this claim. It is known, however, that AMO was aware of problems with their product in 2006, based on its announcement on Nov. 21, 2006, that it was recalling "certain lots" of Complete MoisturePlus after three lots sold in Japan were found to have bacterial contamination. This is according to an FDA press release issued at the time. At the same time, AMO also recalled 18 lots that had been distributed in the U.S. The company cited production line issues at its manufacturing plant in China as the reason for the problem.

When the company made a full recall of Complete MoisturePlus on May 25, 2007, it said in its letter to consumers that there was no evidence that the voluntary recall was related to product contamination and that the date of the letter was the same day the CDC made data available to AMO showing the results of their investigation. As a result, AMO said, it was voluntarily recalling its product as a means of cooperating with the FDA.

The AMO letter correctly advises that the Acanthamoeba organism is common in the environment, but seems to suggest that Acanthamoeba keratitis eye infections are the result of something done by the lens wearer. AMO's letter says the infection is usually found in individuals who improperly store, handle or disinfect their contact lenses by using tap water or homemade cleaning solutions, swim or use hot tubs while wearing their lenses, come in contact with contaminated water, have minor corneal damage or have previous corneal trauma.

As with most lawsuits, it may be several months or more before there is a resolution.

Sources:

Press release, "Hissey Kientz Announced that it Has Filed a Lawsuit in California on Behalf of Three who Were Allegedly Injured after Using AMO Complete;" http://www.prweb.com/releases/2007/12/prweb573037.htm

CDC; http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm

CDC report; http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm

FDA; http://www.fda.gov/oc/po/firmrecalls/advmedical11_06.html

AMO letter; http://www.amo-inc.com/pdf/pr-cmp.pdf