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ROCHESTER, N.Y. (AP) - Bausch & Lomb Inc. said Wednesday 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 Tuesday 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 halted worldwide sales of its new-formula 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 of an unusual spike of Fusarium keratitis cases" in Singapore.
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