Bausch & Lomb has decided to permanently remove from marketsworldwide its ReNu with MoistureLoc contact lens cleaning solution,based on data suggesting that the product may increasesusceptibility to Fusarium. The company has proposed theformulation as the potential root cause of the increased relativerisk of Fusarium keratitis.
Bausch & Lomb has decided to permanently remove from markets worldwide its ReNu with MoistureLoc contact lens cleaning solution, based on data suggesting that the product may increase susceptibility to Fusarium. The company has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis. Speaking at a press teleconference, Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said, "The outbreak of Fusarium appears to be related to the design of this particular solution and the way it is used and some of the use patterns that occur at the user end. It doesn't appear to be a problem with the manufacturing and the way in which the product leaves the facility." As part of a joint CDC and FDA investigation, field officers have been inspecting the Bausch & Lomb plant and facilities in Greenville, S.C., since March 22. ReNu with MoistureLoc contact lens solution, manufactured in the Greenville plant, was voluntarily withdrawn from the U.S. market on April 13.