AMO recalls Complete MoisturePlus contact lens solution

SANTA ANA, Calif. — Advanced Medical Optics is voluntarily recalling its Complete MoisturePlus contact lens solutions in response to data from the U.S. Centers for Disease Control and Prevention showing an increased risk of Acanthamoeba keratitis associated with its use, the company announced.

According to a press release from AMO, the CDC completed interviews with 46 patients who had developed Acanthamoeba keratitis since January 2005, including 39 patients who wore soft contact lenses. Of these 39 lens wearers, 21 reported using Complete MoisturePlus products.

From its investigation, the CDC estimates that the risk of developing Acanthamoeba keratitis is at least seven times greater for those who used Complete MoisturePlus solution vs. those who did not, according to the release.

"There is no evidence to suggest that [the] voluntary recall is related to a product contamination issue, and this does not impact any of AMO's other contact lens care products, including our family of hydrogen peroxide disinfecting solutions," officials for AMO said in the release.

"As patient safety is paramount to AMO, the company is taking 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," the release said.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, MD, a Division of Parasitic Diseases team leader with CDC, in a press release from the U.S. Food and Drug Administration. "We are working with FDA, state, territory, university and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

Both AMO and the FDA ask that any adverse reactions associated with use of Complete MoisturePlus be reported to the FDA's MedWatch Program at www.fda.gov/medwatch.