At Press Time

Lens Cleaner Recall a Complex Issue

Improper Lens Care, Other Factors Cited.

By Jerry Helzner, Senior Editor

■ In late May, Advanced Medical Optics (AMO) voluntarily removed its widely used Complete MoisturePlus contact lens cleaning solution from the global market, citing information received from the U.S. Centers for Disease Control and Prevention (CDC) linking the product to acanthamoeba keratitis (AK), a serious corneal infection caused by a naturally occurring water-borne organism.

To the casual observer, the recall pointed to a direct association between the product and the infection. However, respected voices have raised the possibility that the sharply increased incidence of AK may be due to a combination of factors, some of which were not under the control of AMO. Though much remains to be learned about the link between contact lenses, lens cleaners and eye infections, the ripples caused by this recall may lead to major changes in both contact lenses and lens-cleaning solutions.

Researchers at the University of Illinois Chicago (UIC), who have reviewed the cases of 35 patients treated for AK by UIC ophthalmologists since 2004, believe the infection is not originating in the manufacturing process, but that the cleaning solution is not protecting people from the infection, which they get in their eyes through showering or swimming. The amoeba that causes the infection is naturally present in soil and water. Wearing contact lenses while swimming or in the hot tub appears to increase the risk of infection. The UIC researchers have also theorized that reduced use of chlorine to decontaminate public water supplies, an action mandated by the Environmental Protection Agency, has allowed the acanthamoeba strain to survive in tap water.

"It's not a manufacturing problem or a contamination issue," said Jim Mazzo, president and CEO of AMO. "AK is something the vast majority of contact lens users typically avoid by following their eye practitioner's advice. All of our products have always met and continue to meet FDA requirements. MoisturePlus does what it is designed and approved to do."

Recent lens cleaner recalls by AMO and Bausch & Lomb are already having an effect on producers of contact lenses and lens-cleaning solutions. Some eyecare practitioners are now suggesting that contact lens wearers switch to more expensive daily disposables, which require no cleaning. Daily disposables accounted for only 8% of U.S. contact lens sales in 2006. The recalls may provide a boost to hydrogen peroxide cleaning solutions that act as disinfectants. The recalls also have raised questions about the effectiveness of so-called "no-rub" lens cleaners.

Indeed, in an early June conference call, Mazzo noted that AMO would be placing greater future emphasis on promoting the company's hydrogen peroxide and "rubbing required" lens cleaners. He said that the convenience of no-rub products would probably have to be sacrificed in the interest of making the lens cleaning solutions totally safe and efficacious with all types of lens materials.

The latest recall is the second in 6 months involving Complete MoisturePlus, which accounted for $12.6 million in U.S. sales in the first 3 months of this year and generated approximately $105 million in worldwide revenue in 2006. The earlier U.S. recall was limited to 18 lots of the product produced in China and that came from the same production line at the same time as three other lots that tested positive for bacterial contamination. No incidents of infection were reported in the United States from that possible contamination.

Data on 46 Patients

The CDC data that was made available to AMO contained completed interviews with 46 of a total of 138 patients who were confirmed to have developed AK since January 2005. A total of 39 of the patients interviewed were soft contact lens wearers, 21 of whom reported using Complete MoisturePlus products.

AMO said it has taken decisive action to stop shipments, recall product from the marketplace and encourage consumers to discontinue the use of AMO Complete MoisturePlus until further information is available. Given the potential seriousness of AK infections, AMO is working in close partnership with the CDC, the FDA and others to make sure consumers are aware of the need for proper contact lens disinfection and lens handling.

Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers and heating/ventilation/air conditioning systems. Though 85% of AK cases involve contact lens wearers, the historical incidence of AK in the United States has been estimated by CDC at approximately one to two cases per million contact lens users.

AK symptoms include eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye and excessive tearing. The symptoms, which can last several weeks to 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 patients requiring a corneal transplant if untreated.

Doctors can report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-800-347-5005 and to the FDA-s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md, 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.