On May 26, 2007, the U.S. Food and Drug Administration (FDA) issued an alert to health care professionals and their patients who wear soft contact lenses advising them of a voluntary recall of Complete MoisturePlus Multi-Purpose Solution manufactured by Advanced Medical Optics (now Abbott Medical Optics) of Santa Ana, California. The recall was initiated because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and this eye infection was identified during an investigation by the Centers for Disease Control and Prevention (CDC).
Acanthamoeba keratitis may lead to vision loss, and may eventually require a corneal transplant for some patients. Primarily, the infection affects contact users who are generally healthy. According to the FDA, Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, the CDC determined that the risk of developing AK was at least 7 times greater for those consumers who used Complete MoisturePlus solution versus those who didn’t.
Advice for Consumers
The FDA is advising consumers who wear soft contact lenses to stop using Complete MoisturePlus solution, discard all partially used or unopened bottles, and replace their lenses and storage container. To report any infections from the use of Complete MoisturePlus, call MedWatch, the FDA's voluntary reporting program at 1-800-332-1088 or report online here. Consumers who still have some of the product may call Abbott Medical Optics at 1-888-899-9183 to determine how to return it to the company.
To help prevent eye infections, contact lens users should follow these tips:
Contact a qualified product liability attorney to make sure your rights are protected.