Bausch & Lomb Temporarily Suspends U.S. Shipments of ReNu with MoistureLoc
Bausch & Lomb has announced that it has temporarily suspended shipments in the United States of ReNu with MoistureLoc Multi-Purpose Solution produced at its Greenville, South Carolina manufacturing facility. The suspension is in order to facilitate the further investigation of reports of fungal keratitis infections among contact lens wearers in the U.S. ReNu products manufactured at the U.S. facility are not distributed within Europe, Middle East and Africa. All ReNu multi-purpose solutions, including ReNu with MoistureLoc, sold in Europe, Middle East and Africa, are manufactured by Bausch & Lomb at its facility in Milan, Italy.
Bausch & Lomb has been working closely with the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention to investigate the cases of fungal keratitis. Although the FDA has stated that there is no direct causal relationship between any particular product and the infections, Bausch & Lomb has decided to voluntarily suspend sales of ReNu with MoistureLoc in the U.S. as a precautionary measure while the cause of the incidences is determined. There are no plans to suspend sales of ReNu solutions in the Europe, Middle East and Africa region.
No scientific data exists to suggest a casual relationship between any Bausch & Lomb products and the incidences reported. No unusual trends of fungal keratitis have been reported within Europe, the Middle East and Africa.
All Bausch & Lomb ReNu solutions are manufactured to ISO 13485:2003 standards and rigorously tested for biocidal efficacy. Bausch & Lomb has extensively tested and retested its ReNu contact lens solutions, as well as its manufacturing facilities, and to date, nothing has been found that would support a conclusion that ReNu with MoistureLoc is the cause of any infections.
Bausch & Lomb is cooperating with health authorities and leading experts in the fields of microbiology, epidemiology and ophthalmology in a multi-pronged, multi-national effort to determine the root cause of the incidences. We fully expect to resume shipments of ReNu with MoistureLoc in the U.S. at the conclusion of the investigation.
