Bausch & Lomb Defends Response to Infections
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Bausch & Lomb Inc. said it began discussions with U.S. health regulators within days of receiving reports in February of an unusual incidence of severe fungal infections among contact lens wearers in Singapore.
The Food and Drug Administration said in a preliminary report that the eye-care company failed to properly notify the agency within the mandatory 30 days about 35 cases of potentially blinding Fusarium keratitis infections among people using lens cleaners in Singapore.
But Bausch & Lomb, which permanently ended sales of its ReNu With MoistureLoc lens solution Monday, said it discussed initial case reports with the FDA’s Office of Compliance “within days of receiving a report in February.”
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