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U.S. Department of Health and Human Services

Safety

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Fungal Keratitis Infections Related to Contact Lens Use

Audience: Ophthalmologists, Optometrists, pharmacists, other healthcare practitioners, and consumers

[UPDATE 05/31/2006] On May 15, 2006, Bausch and Lomb announced its decision to permanently remove all ReNu with MoistureLoc products worldwide. As previously recommended, consumers should stop using ReNu with MoistureLoc immediately.

[Posted 04/11/2006; UPDATE 05/15/2006] The FDA and CDC notified all healthcare practitioners and consumers of an increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

Both the FDA and CDC are investigating these occurrences. The CDC received reports of 109 cases of suspected fungal keratitis in 17 different States. Twenty-eight of the 30 cases reported wearing soft contact lenses. The majority of the individuals (26) reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection.

Healthcare practitioners should refer patients presenting with a microbial keratitis immediately to an ophthalmologist for immediate treatment and report cases of fungal keratitis in contact lens wearers to FDA. Contact lens wearers should use good hygiene practices, e.g., wash hands with soap and water, and dry (lint free method) before handling lenses; wear and replace lenses according to the prescribed schedule; follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer; keep the contact lens case clean and replace every 3-6 months; and remove lenses and consult a doctor immediately if the wearer experiences symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

[May 31, 2006 - Public Health Notification - FDA]
[May 15, 2006 - Statement - FDA]
[May 05, 2006 - Update - FDA]
[April 10, 2006 - Advice to Patients - FDA]
[April 10, 2006 - Press Release - FDA]
[April 10, 2006 - MMWR Dispatch - CDC]