The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Bausch & Lomb Inc. failed to formally report, as required by law, thirty-five foreign cases of fungal eye infections linked to one of its contact lens solutions. This reporting failure happened after the company had suspended sales of its ReNu with MoistureLoc solution, and after the FDA had begun an investigation of the manufacturing plant where Bausch & Lomb made the MoistureLoc solution.

Bausch & Lomb suspended U.S. sales in April, and initiated a global recall in May. They later acknowledged the brand of solution was the potential ”root cause” of increased risk of the fungal infection, called Fusarium keratitis. Health officials from Asia and the United Statesreported several hundred cases of Fusarium keratitis. The FDA issued a warning letter which refers in part to the inadequacy of a previous Bausch & Lomb response to FDA concerns about its reporting of the Singapore cases.

Comments are closed.

Of Interest