Information and Resources

FDA Updates Contact Lens Advice

April 21, 2006 -- The FDA has updated its public health notice about soft contact lens use and contact lens solution that may increase the risk for a sight-threatening fungus infection of the cornea called Fusarium keratitis.

On April 13, Bausch & Lomb announced that it is withdrawing all ReNu with MoistureLoc products and is recommending that consumers stop using ReNu with MoistureLoc immediately.

Those products haven't been proven to have caused recent U.S. cases of fungal keratitis, which have been very rare. The withdrawal doesn't apply to other Bausch & Lomb products.

The FDA and 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.

Meanwhile, the FDA sent updated recommendations to health care providers and posted the updated recommendations on its web site.

Updated Recommendations

Here are the FDA's updated recommendations for contact lens wearers:

• Stop using Bausch and Lomb ReNu with MoistureLoc products and discard all remaining MoistureLoc solution including partially used or opened bottles.
• Consult your eye care professional concerning use of 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 hands with soap and water, and dry (lint-free method) before handling lenses.
  • Wear and replace lenses according to the schedule prescribed by the doctor.
  • 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.
  • 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.

The FDA also posted these updated recommendations for health care providers:

• Advise patients to stop using Bausch & Lomb ReNu with MoistureLoc products immediately, discard all remaining MoistureLoc solution, and use an alternative cleaning/disinfecting product.
• If a patient has microbial keratitis, consider that a fungal infection may be involved.
• Prior to initiating immediate treatment, an eye care professional should obtain a specimen for laboratory analysis.
• Report cases of fungal keratitis in contact lens wearers to the FDA.

Background on Rare Eye Fungus Reports

On April 10, the CDC announced that it had gotten reports of 109 suspected cases of fungal keratitis in 17 different states. At the time, most patients hadn't been interviewed, but the CDC had complete data for 30 of them.

Of those 30 patients, 28 wore soft contact lenses, 26 of whom reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection, the FDA states. Five of those patients also reported using other solutions in addition to the ReNu product, and nine reported wearing lenses overnight, a known risk factor for microbial keratitis.

The FDA's latest letter to health care providers doesn't include any updated statistics on the fungal keratitis cases.