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Bausch and Lomb withdraws MoistureLoc permanently
Bausch and Lomb’s decision to withdraw MoistureLoc worldwide has been met with approval from the FDA.
The announcement comes after the eye-care company suspended shipments of the multi-purpose contact lens solution due to a reported increase in the number of cases of fungal keratitis.
Bausch and Lomb blames a unique set of circumstances whereby the formulation of the solution could allow the cultivation of the fungus Fusarium, which can produce mycotoxins that are harmful to human tissues. It is also a cause of keratitis, which is an inflammation of the cornea – not dissimilar to conjunctivitis in terms of some symptoms.
Ronald L. Zarrella, chairman and chief executive officer, said: “Bausch and Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products.”
“After an extensive investigation involving thousands of tests, millions of dollars and collaboration with government agencies, health authorities and independent experts, there is no evidence of product contamination, tampering, counterfeiting or sterility failure,” he added.
Mr Zarrella concluded: “That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances.”
The company added that it was withdrawing the product where it had not seen increased reports of its MoistureLoc customers catching fungal keratitis, such as China, Europe and the Middle East. It said it has not yet estimated the financial impact the move would have on its earnings for 2006 and that investigations into the cause of the problem were continuing.
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