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FDA Investigates Eye Fungus Linked to Contact Lens Solution

Microbial keratitis is a severe infection of the cornea of the eye. A fungal keratitis infection is caused by the fungus, Fusarium, and may cause vision loss requiring corneal transplants. Fusarium infection is not spread from one person to another. The annual incidence of microbial keratitis is relatively rare, about 4-21 per 10,000 soft contact lens users, and is linked to overnight lens use. However, on March 18, 2006, 109 U.S. cases of fungal keratitis were reported to the Centers for Disease Control and Prevention (CDC). The cases were reported from 17 U.S. states including California, Connecticut, Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, and Vermont.

The U.S. Food and Drug Administration (FDA) has announced that the recent U.S. outbreak of eye fungus is linked to ReNu with MoistureLoc contact lens solution produced by Bausch & Lomb. "Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis in an effort to determine all contributing factors and/or products that place contact lens wearers at increased risk for Fusarium keratitis," states the FDA Public Health Notification. "The CDC findings continue to show an increased risk for Fusarium keratitis linked to using Bausch and Lomb's ReNu with MoistureLoc in the month prior to the onset of infection."

Symptoms of fungal infection include redness, eye pain, excessive tearing, discharge, and sensitivity to light. Diagnosis of fungal keratitis requires a corneal scraping specimen for culture. Treatment includes topical and oral antifungal medications. Corneal transplant may be recommended if drug treatment is not successful.

The FDA recommends that contact lens wearers:

1. Stop using Bausch and Lomb ReNu with MoistureLoc products and discard all remaining Moisture Loc solution bottles.

2. Consult with their eye doctor concerning use of an appropriate cleaning/disinfecting product.

3. Wear and replace lenses and follow the lens cleaning and storage guidelines as prescribed by the doctor.

4. Perform a "rub and rinse" lens cleaning method, rather than a no rub method.

5. Wash hands with soap and water, and dry (lint-free method) before handling lenses.

6. Keep the contact lens case clean and replace every 3-6 months.

7. Remove the lenses and consult with a doctor immediately if experiencing symptoms such as eye redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, .

REFERENCES:
1. FDA Public Health Notification: Fungal Keratitis Infections Related to Contact Lens Use, FDA, May 31, 2006: http://www.fda.gov/cdrh/safety/041006-keratitis.html

2. The Associated Press, Fungus has contact wearers groping for glasses, USAToday, April 18, 2006: http://www.usatoday.com/news/health/2006-04-18-eye-fungus_x.htm

Posted by Elaine Gavalas on August 10, 2006 02:49 PM


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