FDAnews Device Daily Bulletin

BAUSCH & LOMB FACES LAWSUITS OVER CONTAMINATED EYE CARE SOLUTION

April 25, 2006
A A

Bausch & Lomb is being sued by claimants for recent incidences of Fusarium keratitis, a painful fungal infection that can cause blurred vision and potentially lead to blindness.

A class action lawsuit announced recently in Miami is being brought by attorney Joel Magolnick on behalf of a 57-year-old Fort Lauderdale, Fla., woman and more than 100 other plaintiffs. Jacqueline Wartmann says her cornea was scarred after using Renu with MoistureLoc eye solution. Magolnick is seeking $75,000 in damages per person.

A New York man sued Bausch & Lomb on the same day in federal court in New York City. Nelson Huie is accusing the company of engaging in deceptive marketing practices and failing to publicly disclose an inherent defect in its ReNu with MoistureLoc solution that makes the product susceptible to Fusarium keratitis.

Huie alleges the company knew of the link between the product and increased incidences of Fusarium keratitis in Asia as early as February, but did not suspend sales of the product in the U.S. until cases of the infection became public in recent weeks.

The primary facility linked to the faulty products is the company's optical solutions plant in Greenville, S.C., which manufactures the bulk of Bausch & Lomb eye-care solutions sold in the U.S. and Asia. The company stopped all shipments of ReNu from that facility to Asia in February after a slew of infections were reported in Singapore, Hong Kong and Malaysia. Prior to the recent spate of infections, the facility had not been inspected by the FDA for three years.

Bausch & Lomb was issued an FDA warning letter in July 2002 for processing issues at the South Carolina plant. The facility was cited for inadequate validation procedures related to determining "the proper amount of solution that should be flushed through the filling lines prior to packaging." The facility also had "out-of-specification (OOS) results in finished product testing" for certain amounts of an unnamed substance that is "the preservative [and] disinfectant in the majority of your eye care products," the warning letter states. The facility was also cited for inadequate procedures for finished device acceptance related to the amounts of preservative in its products.

(http://www.fdanews.com/ddl/33_17/)