ROCKVILLE, Md., May 29 -- A possible parasitic contamination of a solution for soft contact lens wearers has triggered a national recall.
ROCKVILLE, Md., May 29 -- A possible parasitic contamination of a cleansing solution for soft contact lens wearers has triggered a national recall of the product.
Following reports of a possible increased risk of Acanthamoeba keratitis among soft contact lens wearers who used Complete MoisturePlus Multi Purpose Solution, Advanced Medical Optics of Santa Ana, Calif., issued the recall.
The FDA said the link between the solution and the rare but serious infection, which is caused by a parasite, was identified by the CDC. The FDA urged wearers of soft contact lenses to stop using the solution, discard all partially-used or unopened bottles, and replace their lenses and storage container.
According to the CDC, Acanthamoeba keratitis infections occur in approximately two of every one million contact lens users in the United States. But a multi-state investigation by the CDC found that the risk was seven times greater for those consumers who used Complete MoisturePlus versus those who did not.
Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, said the company acted responsibly in issuing the recall. "FDA and CDC are working closely with the company to collect additional information, and we will continue to alert consumers and advise them as more information becomes available," Dr. Schultz said.
Acanthamoeba keratitis, which primarily affects otherwise healthy people who wear contact lenses, may lead to vision loss, with some patients requiring a corneal transplant.
The symptoms of difficult-to-treat.Acanthamoeba keratitis can be similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing.
A year ago Bausch & Lomb pulled its ReNu with MoistureLoc solution off the market when it was linked to an outbreak of another rare, but serious infection--Fusarium keratitis.
The FDA said consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment.
The FDA advised contact lens wearers to follow these procedures to reduce the risk of eye infections: