The FDA has discovered 35 ReNu-related fungal infections in Singapore in mid 2005. But, the lips of Bausch & Lomb were sealed. See no evil is not a good drug company motto.
FEDS FOCUS ON EYE-FUNGUS FIRM’S SILENCE
May 17, 2006 — Bausch & Lomb Inc. failed to promptly notify federal regulators about 35 cases of a potentially blinding fungal infection among contact-lens wearers in Singapore who reported using its newest contact lens cleaner, the Food and Drug Administration said yesterday.
The eye-care company permanently pulled its ReNu with MoistureLoc solution from markets worldwide Monday as health officials investigate its links to an outbreak of Fusarium keratitis infections dating to June 2005.
The failure to notify the FDA about the Singapore infections within 30 days was among 20 potential violations the agency listed after inspecting a Bausch & Lomb factory in Greenville, S.C., where MoistureLoc was made for the U.S. market and several in Asia
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