If you wear soft contact lenses, your cleaning solution may be putting you at risk for fungal keratitis, a rare but serious eye infection caused by the Fusarium fungus. Bausch and Lomb has announced that it's removing all of its ReNu with MoistureLoc products from store shelves worldwide, and recommends that anyone using these products stop immediately because they have been linked to several cases of fungal keratitis. There are no generic or private labeled brands made using the ReNu with MoistureLoc solution.

What is fungal keratitis?

Fungal keratitis is an inflammation of the cornea, the front part of the eye. It can cause permanent loss of vision, and can appear similar to other eye infections. Any red or painful eye should be examined by your doctor right away.

What are the symptoms?

• Unusual redness
• Eye pain
• Tearing
• Light sensitivity
• Blurry vision
• Discharge
• Swelling

What should I do if I’ve been using these products?

• Stop using Bausch and Lomb ReNu with MoistureLoc products immediately and throw away all remaining MoistureLoc solution including partially used or unopened bottles.
• Consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
• Ask your doctor for help in choosing an alternate cleaning/disinfecting product.
• Follow proper lens care practices.
• What lens care practices should I follow?
• Wash your hands with soap and water, and dry them with a lint-free cloth before handling your lenses.
• Wear and replace your lenses according to the schedule prescribed by your doctor.
• Follow the lens cleaning and storage instructions of your doctor and your solution manufacturer.
• Regardless of which cleaning/disinfecting solution you use, consider performing a "rub and rinse" lens cleaning, rather than a no rub cleaning, in order to minimize the number of germs and reduce the chances of infection.
• Keep your contact lens case clean and replace it every 3-6 months.

Have there been reported cases of fungal keratitis?

The Centers for Disease Control and Prevention (CDC) has seen an increasing number of reports of fungal keratitis. In nearly all of the cases patients used a Bausch and Lomb ReNu brand contact lens solution, or a generic product manufactured by the same company.

While Fusarium fungus has not been identified in the product or in the manufacturing facility FDA, CDC, state and local health departments, and Bausch and Lomb are continuing to investigate the situation. One focus of the investigations is to see if either certain behaviors of contact lens wearers, or specific contact lens products increase the risk of infection.

Should I report symptoms of fungal keratitis to FDA?

If you’ve had any symptoms of infection FDA would like to hear from you. You can report directly to MedWatch, the FDA's voluntary reporting program by:

• phone at 1-800-FDA-1088
• FAX at 1-800-FDA-0178
• mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787
• online at http://www.fda.gov/medwatch/report.htm.

Please include information to as many of the following questions on the MedWatch reporting form:

• What brand of contact lens cleaning solution, if any, do you use?
• What is the lot number and expiration date printed on the package?
• What brand/type of contact lenses do you use?
• Do you remove your lenses overnight?
• Do you have any ongoing health concerns (e.g. diabetes)?
• Are you using any medication in the treatment of your eyes?

Where can I get more information?

Additional questions regarding the market withdrawal of Bausch and Lomb ReNu with MoistureLoc products should be directed to Bausch and Lomb at 1-888-666-2258.

If you have any concerns about your contact lenses, 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.