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FDA > CDRH > Medical Device Safety > Public Health Notifications > Advice for Patients With Soft Contact Lenses: New Information on Risk of Serious Fungal Infection

Advice for Patients With Soft Contact Lenses: New Information on Risk of Serious Fungal Infection

Updated: April 21, 2006

Original publication date April 10, 2006

Dear Contact Lens Wearer,

This is to update you on the rare but serious eye infection in people who wear soft contact lenses. There has been a recent increase of reports in the U.S. of this infection. The infection is fungal keratitis, caused by the Fusarium fungus. It can cause a permanent loss of vision. Several patients with this infection have needed corneal transplants to save their vision.

New Information

On April 13, 2006, Bausch and Lomb announced a market withdrawal of all ReNu with MoistureLoc products. This means the company is removing all ReNu with MoistureLoc products off the store shelves. Bausch and Lomb is recommending that consumers stop using ReNu with MoistureLoc immediately.

Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis to determine all contributing factors and/or products placing contact lens wearers at risk for Fusarium keratitis.

We will continue to update this notice as more information becomes available.

Updated Recommendations

If you wear soft contact lenses, you should:

Stop using Bausch and Lomb ReNu with MoistureLoc products immediately and discard all remaining MoistureLoc solution including partially used or unopened bottles.
Consult your doctor about choosing an appropriate alternative cleaning/disinfecting product.
Consider performing a “rub and rinse” lens cleaning method, rather than a no rub method, regardless of which cleaning/disinfecting solution used, in order to minimize the number of germs and reduce the chances of infection.
Continue to follow proper lens care practices:
- Wash your hands with soap and water, and dry (lint-free method) them before handling your lenses.
- Wear and replace your lenses according to the schedule prescribed by your doctor.
- Follow instructions from your doctor and your solution manufacturer for cleaning and storing your lenses.
- Keep your contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

Additional questions regarding the market withdrawal of Bausch and Lomb ReNu with MoistureLoc products contact the company at 1-888-666-2258.

If you have any concerns about your contact lenses, you should contact your doctor. You may also contact FDA’s Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041. For consumer information, select # 2, or to speak with a Medical Device Specialist, select # 4.

Additional information on this topic for healthcare providers can be found at: http://www.fda.gov/cdrh/safety/041006-keratitis.html. Additional information for the public can be found at: http://www.fda.gov/oc/opacom/hottopics/contacts.html.

Updated May 30, 2006

horizonal rule

Center for Devices and Radiological Health / CDRH