Bausch & Lomb announced on May 15th that it was permanently recalling its ReNu with MoistureLoc contact lens solution worldwide after reports the product might trigger a rare fungal eye infection.
"Bausch & Lomb's top priority is the safety of our customers, and we want them to have complete confidence in our products." said Bausch & Lomb CEO Ronald L. Zarrella.
The U.S. Centers for Disease Control and Prevention reported on May 12th that health officials had confirmed 122 cases of fusarium keratitis, which can cause corneal scarring and blindness, that might be related to use of the Bausch & Lomb lens solution.
Symptoms of fusarium keratitis, which can cause corneal scarring and blindness, include redness, blurry vision, discharge, swelling, tearing, pain and increased sensitivity to light.
Bausch & Lomb said its investigation of the problem produced no evidence of product tampering or contamination, leading the company to conclude that "some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances."
The U.S. Food and Drug Administration, in a related development, said it had found some irregularities at Bausch & Lomb's ReNu plant in Greenville, S.C., but said plant issues were not related to the outbreak of Fusarium keratitis.
FDA officials said it appeared that the MoistureLoc formulation does not cause the infection, but does not block it from occurring in rare cases.
U.S. Food and Drug Administration officials said Monday that the formula used to make MoistureLoc contributed to higher probability of Fusarium keratitis in some patients.
"There does seem to be an interface between where the organism lives and where the solution is used," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The orgasism appears to be living in and around bathrooms.