May 17, 2006
Bausch Says It Discussed Infections with US FDA
CHICAGO (Reuters) - Troubled eye products maker Bausch & Lomb Inc. said on Wednesday it had discussed initial case reports with U.S. regulators within days of receiving a report in February of an unusual spike of serious eye infections in Singapore.
The U.S. Food and Drug Administration on Tuesday released an inspection report on one of Bausch & Lomb's plants that noted the company had not reported the issue to the agency within the mandatory 30-day time frame.
In its inspection report, the FDA said: "The firm failed to notify the Agency of 35 serious injury reports of Fusarium Keratitis from Singapore's Minister of Health in February 2006 relating to ReNu MoistureLoc Multi-Purpose Solution."
The FDA report said "none of the complaints were reported to the agency as of April 7, 2006."
The finding was among 20 observations of potential violations the FDA listed after inspecting two of the company's facilities in Greenville, South Carolina.
Bausch defended its actions. "As details of the Singapore cases were gathered, the company continued to provide updates to the FDA," the company said in statement.
Bausch said after receiving guidance from the FDA, it filed a medical device report on April 7.
The FDA said on Tuesday the manufacturing problems were unrelated to the Fusarium outbreak.
On Monday, Bausch permanently recalled its ReNu with MoistureLoc contact lens solution from all global markets, saying the product may increase the risk of Fusarium keratitis, a rare and potentially blinding fungal infection.