In response to reports received from the Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, Advanced Medical Optics (AMO) has voluntarily recalled its Complete MoisturePlus contact lens solutions. No evidence suggests that the voluntary recall is related to a product contamination issue, according to AMO. The company is working with the CDC, FDA, and others to ensure that consumers are aware of the need for proper contact lens disinfection and proper lens handling.
The recall by AMO, announced May 25, followed an initial analysis by the CDC using data from the first completed interviews with 46 (of 138) patients. In its May 26 Morbidity and Mortality Weekly Report (MMWR) Dispatch, the CDC said 39 of the patients identified themselves as wearers of soft contact lenses. Of these, 36 patients reported using one or more types of contact lens solution, 21 reported using the recalled solution in the month before symptom onset, 20 reported using the recalled solution as their primary solution, and 14 reported using it as their exclusive solution.
AMO initiated the product recall within hours of learning of the CDC's report-which estimated a risk of at least seven times greater for those who used the solution versus those who did not.
"We had limited information, no opportunity to conduct our own research, but a clear indication from the CDC and FDA that they believed the recall was appropriate," Mazzo said. "The bottom line is that we take our commitment to safety very seriously and we therefore decided, out of an abundance of caution, that we would voluntarily recall the product."
The global recall of the product, in all of its forms, began immediately. AMO spokes-man Steve Chesterman said it was unknown how many units were in distribution warehouses, homes, or on store shelves.
The company's line of MoisturePlus products represented $105.7 million in 2006 sales, or 10% of total consolidated sales, said Randy Meier, AMO's chief operating officer and chief financial officer. AMO officials are considering whether it's safer to return to contact lens cleaning solutions that require patients to rub lenses before disinfecting, or those that use hydrogen peroxide, a stronger disinfectant commonly used in Europe, Meier told analysts during the conference call.
How it started
CDC launched its own investigation to confirm the work being done by researchers at the University of Illinois at Chicago (UIC). There, ophthalmologists and Charlotte E. Joslin, OD, who is completing work on her PhD in epidemiology, had noted a marked increase in the number of Acanthamoeba keratitis cases in recent years.
In August 2006, they published a study in the American Journal of Ophthalmology (Epidemiological characteristics of a Chicago-area Acanthamoeba keratitis outbreak. Am J Ophthalmol. 2006 Aug;142: 212-217) theorizing a link with the city's water supply. Dr. Joslin said she suspects a connection between the water-borne pathogen and reduced amounts of disinfectants that the EPA now allows in the water supply.