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Recall: Complete MoisturePlus Contact Lens Solution

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.

Steps for Consumers

If you wear soft contact lenses, you should:

• Stop using Complete MoisturePlus Contact Lens solution.
• Discard all partially used or unopened bottles.
• Replace your contact lenses and storage container.
• Ask your doctor about choosing an appropriate alternative cleaning/disinfecting product.
• Seek immediate treatment if you have symptoms of eye infection--eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing. Early diagnosis is important for effective treatment.

If you believe that you have the recalled product, you may call the company at 1-888-899-9183.

About Acanthamoeba Keratitis

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.

Measures to Help Prevent Eye Infections

All contact lens wearers should adhere to these measures to help prevent eye infections:

• Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
• Wash hands with soap and water and dry them before handling contact lenses.
• Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
• Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
• Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
• Schedule regular eye exams with your eye care professional.
• Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
• Store lenses in a proper storage case.Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
• Replace storage cases at least once every three months.

Report Adverse Events

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

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