Lens wearers not at fault in ReNu recall outbreak

Wednesday, 23 August 2006

A new report from the Centers for Disease Control and Prevention says that poor hygiene was not responsible for an outbreak of the fungal infection Fusarium keratitis among users of Bausch & Lomb’s ReNu with MoistureLoc contact lens solution. Bausch & Lomb had previously claimed that poor hygiene practices by consumers contributed to the outbreak. The company issued a worldwide ReNu recall in May after MoistureLoc was linked with Fusarium keratitis symptoms in the U.S., Europe and Asia. The CDC report, published in the Journal of American Medicine, says the most likely cause of the infection outbreak was a problem in ReNu’s ability to disinfect contact lenses. Inspections of Bausch & Lomb’s Greenville, South Carolina plant found no evidence of contamination during the manufacturing process. CDC inspections of unopened MoistureLoc bottles, contact lenses or lens cases also failed to uncover evidence of Fusarium contamination. CDC investigators now say that they are turning their attention to two ingredients in MoistureLoc that are not found in other contact lens solutions. They believe that these “unique properties” may have caused the outbreak of Fusarium keratitis symptoms that necessitated the ReNu recall. The CDC has been able to identify 164 cases of Fusarium infections spread across 34 states so far, according to the latest statistics. About 94% of these were users of soft contact lenses. Patients who displayed Fusarium keratitis symptoms were 20 times more likely to use ReNu with MoistureLoc than another contact lens solution. About one-third of the affected patients required corneal transplants. Douglass Kreis, a ReNu lawyer for a woman who filed a ReNu lawsuit in Florida, says that the CDC study will play a key role in helping to explain why the Fusarium outbreak occurred. “The study not only definitively supports the association between ReNu with MoistureLoc and Fusarium keratitis but concurrently undermines Bausch & Lomb’s argument that consumers were at fault,” Kreis says.