FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
FDA is alerting health care professionals and patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution. The company, Advanced Medical Optics of Santa Ana, Calif., is taking this action as a precaution because of reports of a rare but serious eye infection, Acanthamoeba keratitis, caused by a parasite.
"We believe the company acted responsibly in taking this voluntary action and support the decision to be proactive in the interest of public health," says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health.
If you wear soft contact lenses, you should:
If you believe that you have the recalled product, you may call the company at 1-888-899-9183.
A serious eye infection: The symptoms of Acanthamoeba keratitis can be very 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 but Acanthamoeba is more difficult to treat. Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.
Recent increase in cases: The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC). It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. But in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing Acanthamoeba keratitis was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not.
Ongoing investigation: FDA and CDC are working closely with the company to collect additional information and will continue to advise consumers as more information becomes available. Experts are collaborating to further understand whether usage or contamination of this solution led to these Acanthamoeba infections.
All contact lens wearers should adhere to these measures to help prevent eye infections:
FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.
For more information about CDC's multi-state investigation, visit www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm
For more information about Acanthamoeba infection, visit www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm
Date Posted: May 29, 2007