Eye Fungus Attributed to Solution Formulation and Non-Compliance

Optometric Management, Jun 2006

B&L RECALLS CONTACT LENS SOLUTION

In response to the incidence of Fusarium keratitis among soft contact lens wearers, eyecare professionals re-evaluated the management of contact lens patients, while Bausch & Lomb announced it would permanently remove its MoistureLoc solution from world markets.

B&L announced the voluntary recall on May 15, citing customer safety as a top priority. An investigation by the U.S. Centers for Disease Control and Prevention (CDC) reported that in cases of Fusarium infection among contact lens wearers who could identify their solutions (118 persons), 64% reported using MoistureLoc alone and another 12% reported using MoistureLoc with another product.

The CDC concluded that MoistureLoc was the only product with a statistically significant association with reports of Fusarium. As testing by the manufacturer and health authorities revealed "no evidence of product contamination, tampering counterfeiting or sterility failure," B&L concluded some aspect of the formulation was responsible.

Further tests by B&L found a disinfecting agent in MoistureLoc, alexidine, was safe and effective when the solution was used properly. However, evaporation of the solution can lead to a higher concentration of polymers that may make the solution more likely to be contaminated with Fusarium.

Brian Levy, O.D., M.Sc., chief medical officer, B&L, noted that the "extensive R&D effort" found that polymers in the MoistureLoc formulation could create films under certain conditions of use, in particular evaporative conditions. "This could occur in a number of instances - for example, when solution is 'topped off in lens cases instead of changing solution daily, when bottles are left open between uses and polymer forms around the tip or in the cap, or when cases are not cleaned properly or changed regularly. The polymer film, which may form on the bottle tip or in the case, reduced efficacy of the disinfectant and provided an environment protective of Fusarium with the MoistureLoc formulation," said Dr. Levy. "Under similar test conditions, efficacy remained high for ReNu MultiPlus, which does not contain the polymer content of MoistureLoc."

As of May 18, the CDC reported 130 confirmed cases of Fusarium keratitis and of these 125 reported wearing contact lenses. "We advise patients that infections are extremely rare, but they should report any incidents of red or painful eyes to us immediately," says Sheldon Kreda, O.D.

Andrew S. Gurwood, O.D., provides strict instructions for lens care including: clean contact lenses twice a day, keep lenses in a clean case, discard lenses at the prescribed time, do not sleep in lenses, do not change solutions "randomly" and remove lenses and call the practice ASAP in the case of discomfort or red eyes.

Paul Karpecki, O.D., says he was "shocked" at how few patients were honestly compliant when he brought up hygiene issues. "About 90% had taken numerous shortcuts in contact lens care," he notes.

Dr. Karpecki says the incidence of poor contact lens compliance "is up substantially from where it was before the 'no-rub' marketing."

"In my practice, I have taken steps to review patient compliance, to dismantle the entire idea of norub, and to inform patients of the risks associated with poor hygiene related to contact lens wear," says Dr. Karpecki.