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Faulty Renu MoistureLoc Testing Responsible for 2006 Fusarium Keratitis Outbreak

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Bausch & Lomb’s Renu with MoistureLoc Contact Lens Solution was tested against an outdated strain of Fusarium that was an inadequate example of the types of pathogens that exist today. According to a study conducted by researchers at the Centers for Medical Mycology at University Hospitals Case Medical Center in Cleveland, Ohio, the quality testing Bausch & Lomb routinely performed on Renu with MoistureLoc and other contact lens solutions was no guarantee of their effectiveness. The researchers have concluded that such faulty test methods were directly responsible for the massive 2006 outbreak of Fusarium Keratitis linked to defective Renu MoistureLoc.

These latest findings have bolstered many Bausch & Lomb critics, who have long blamed the company’s poor quality control measures for the outbreak of the potentially blinding disease. “It’s ridiculous that a contact lens solution would only be tested against a microbe that has no real world relevance,” said Jerrold Parker, Managing Partner of Parker Waichman LLP, a law firm representing many Renu with MoistureLoc victims. “There is no way Bausch & Lomb could guarantee the safety of Renu MoistureLoc on the basis of these inadequate tests.”

In 2006, Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

Now, researchers led by Mahmoud A. Ghannoum, Ph.D., director of the Center for Medical Mycology, have discovered one important factor behind inability of Renu with MoistureLoc to resist contamination with the fungus Fusarium. A study done at the center has found the strain of Fusarium responsible for the Renu with MoistureLoc outbreak had the ability to form biofilms. Biofilms are clusters of microbes held together by a glue like matrix. This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system.

Not all cells can form biofims, and unfortunately for Renu victims, contact lens solutions are not required to be tested against microbes with this ability. In fact, Renu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s.

Scientists at the Center for Medical Mycology used three strains of Fusarium – two recent strains and the one from the 1970s used by Bausch & Lomb – to run their own tests of Renu with MoistureLoc. While Renu was effective in deterring the 1970s fungus, it was unable to penetrate the matrix formed by the recent Fusarium samples. The inability to penetrate these biofilms meant that Renu with MoistureLoc users had no protection against particularly virulent strains of Fusarium.

Their findings have led the researchers at The Center for Medical Mycology to call for changes in the way contact lens solutions are tested. “We recommend that solutions be tested for biofilms produced by more recent clinical isolates,” Ghannoum said. “One of the underlying reasons for Renu with MoistureLoc not being effective against the recent outbreak of keratitis is that solution is not effective against biofilms and the organisms in biofilms.”

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