FDA: Bausch & Lomb Didn't Disclose CasesMay 6, 2006 | AP
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 Tuesday.
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 back 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 markets in the United States and several Asian markets.
The company also did not notify the FDA in writing that it had removed MoistureLoc from the Singapore and Hong Kong markets in February. In addition, it failed to follow some proper procedures to prevent contamination of equipment at its Greenville plant, the FDA said.
So far, preliminary results from testing of "environmental factors, raw materials, in-line manufacturing processes and finished products" at the factory "have not found that these factors have contributed to Fusarium contamination," the agency said.
Without treatment, which can last two to three months, the fungal infection can scar the cornea and blind its victims.
Of the more than 30 million Americans who wear contact lenses, about 2.3 million used MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year.