The US Centers for Disease Control (CDC) is studying Bausch’s ReNu MoistureLoc solution, which was voluntarily removed from the market earlier this year, as part of its investigation into the outbreak of a number of cases of the serious eye infection Fusarium keratitis.
Bausch said it will fully cooperate with the FDA and the CDC in a comprehensive investigation to determine the root cause of the unusual incidence of fungal keratitis. The company is due to meet with the CDC to discuss its findings so far.
Studies suggest that Fusarium keratitis occurs among contact lens wearers at a low rate. Bausch points out that it would then be expected that the distribution of lens care products associated with these cases would be roughly proportional to the products’ relative market share.
Although cases of infection among patients using Bausch’s ReNu MultiPlus solution fall well below the product’s market share, its MoistureLoc version has been correlated with a disproportionately high number of cases.