FDAnews Device Daily Bulletin

BAUSCH & LOMB ASKS RETAILERS TO REMOVE SOLUTION

April 17, 2006
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Bausch & Lomb asked U.S. retailers to remove ReNu with MoistureLoc from their shelves temporarily, and recommended that consumers switch to another lens care solution, until the investigation of reports of fungal keratitis infections among contact lens wearers is concluded.

The company initiated the voluntary market withdrawal in order to eliminate any confusion among contact lens wearers about what to do while the investigation is ongoing.

The company placed ads in USA Today and regional newspapers on April 14 and 16, featuring an open letter to consumers from Bausch & Lomb Chairman and CEO Ron Zarrella explaining the situation.

"We find ourselves in a position where the safety of one of our products, ReNu with MoistureLoc manufactured at our United States plant, is in question," said Zarrella in his letter.

"We've done a series of exhaustive tests on the product, and a thorough inspection of the plant, and nothing has yet been found to show that ReNu with MoistureLoc contributed to these infections in any way. However, in the case of infections reviewed to date, the majority of patients reported using ReNu with MoistureLoc manufactured at our U.S. factory," he said.