Bausch & Lomb failed to report fungal cases

Bausch & Lomb failed to report 35 cases of Fusarium keratitis linked to its ReNu with MoistureLoc solution, according to an 11-page warning letter from the Food & Drug Administration in the US.

The contact lens company was required by law to report the cases identified by the Ministry of Health in Singapore (News, February 21) to the FDA.

Regulations in the US dictate that a report should be submitted to the FDA within 30 days of receiving information suggesting that a medical device may have caused or contributed to a death or serious injury.

The letter refers to a previous response by B&L regarding this lack of reporting, which the FDA concluded was 'inadequate'.