FDA Upset with Contact Lens Solution Maker Over Reporting

November 2007

Bausch and Lomb neglected to report over three dozen foreign cases of Fusarium keratitis, a fungal eye infection linked to one of its contact lens solutions, claims a warning letter from the Food & Drug Administration (FDA).

The FDA said the contact lens solution manufacturer was alerted by Singapore health officials of the 35 cases of eye injury and failed to report the cases by April 7, as specified by law.

Bausch & Lomb stopped selling its ReNu with MoistureLoc lens solution in Singapore and Hong Kong in February of this year but didn’t stop selling the contact lens solution in the U.S until April 2006.

Fusarium keratitis affected hundreds of MoistureLoc users in the United States but the reason the solution caused the eye infections was never determined. Left untreated, F. keratitis can cause blindness.

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