AMO works with CDC, FDA regarding recalled multipurpose solution

Santa Ana, CA-Advanced Medical Optics (AMO) is continuing to work with the Centers for Disease Control and Prevention (CDC) and the FDA to assess CDC data that led to the company’s voluntary recall of its multipurpose contact lens-cleaning solution (Complete MoisturePlus) May 25.

As of May 24, public health authorities and ophthalmologists from 35 states and Puerto Rico had reported to the CDC a total of 138 patients who had experienced the onset of symptoms of Acanthamoeba keratitis and positive Acanthamoeba cultures from corneal specimens since Jan. 1, 2005. State and local health officials and the CDC are continuing to interview patients, ophthalmologists, and primary eye-care providers. Laboratory testing of clinical specimens, contact lenses, bottles of solution, and contact lens cases received from patients with Acanthamoeba keratitis is ongoing.

The recall followed an initial analysis using data from the first 46 completed patient interviews. Thirty-nine of the patients identified themselves as wearers of soft contact lenses, 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. According to the CDC, users of the solution are seven times more likely to develop Acanthamoeba keratitis than are people who do not use the solution.

AMO maintains that no evidence suggests that the keratitis is related to a product contamination issue. “Acanthamoeba keratitis is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma,” according to a statement released by the company.

The company is contacting retailers, customers, and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for product returns.

Adverse reactions and quality problems may be reported by calling AMO at 800/347-5005 or by contacting the FDA’s MedWatch Program by phone at 800/332-1088, by fax at 800/332-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or by visiting the MedWatch Web site, www.fda.gov/medwatch.

The recall does not affect any of the company’s other contact lens-care products.