Bausch & Lomb Renu with MoistureLoc Tests Faulty, New Study SaysJan 28, 2008 | Parker Waichman LLP
Renu with MoistureLoc, the Bausch & Lomb contact lens solution that was responsible for a massive outbreak of Fusarium Keratitis in 2006, was never adequately tested to insure that it was resistant to microbial contamination. According to a new study conducted by researchers at the Center for Medical Mycology at University Hospitals Case Medical Center in Cleveland, Ohio, the strain of Fusarium used by Bausch & Lomb to test Renu with MoistureLoc was rare and outdated, making tests with the strain a poor indicator of the contact lens solution’s effectiveness.
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.
This new study is only further evidence that Bausch & Lomb did not do enough to insure the quality of its contact lens solution. “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.”
The researchers at The Center for Medical Mycology agree. “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.”