Bausch & Lomb Issues Global Recall of Contact Solution
Recall comes on heels of withdrawal of ReNu with MoistureLoc from U.S. market
TUESDAY, May 16 (HealthDay News) -- Bausch & Lomb has issued a global recall of its ReNu with MoistureLoc contact lens cleaning solution product because it can increase the risk of Fusarium infection, according to the U.S. Food and Drug Administration.
The company's decision was based on an internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc, which was voluntarily withdrawn from the U.S. market on April 13. The recall does not affect the company's ReNu MultiPlus or ReNu Multi-Purpose brands, or generic brands of this contact lens cleaning solution, which to date have not been associated with Fusarium infection.
"While FDA is still concluding its scientific evaluations and expects additional information to be submitted by the sponsor, at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product," the FDA states. "FDA will continue to review cultures and epidemiological data and if there is new information that adds to or changes our current understanding, we will act on it in a timely and appropriate manner."