Bausch & Lomb halts US shipments of lens solution
Bausch & Lomb agreed to stop shipping its ReNu MoistureLoc brand contact lens solution in the United States after some users were diagnosed with a serious eye infection, the Food and Drug Administration said on Monday.
Bausch & Lomb suspended sales of all ReNu solutions in Singapore and Hong Kong in February after reports of similar infections, although the company later said that tests found no evidence to suggest its products were the cause.
The FDA said 109 preliminary reports of a rare fungal infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention from 17 U.S. states.
The agency said it was not aware of a direct link between the Fusarium fungus and any specific product, but in 26 cases so far, patients used Bausch & Lomb's ReNu MoistureLoc solution.
"We do not at this point have information that gives us a direct cause-and-effect link between any particular product or any particular action," Dr. Daniel Schultz, head of FDA's Center for Devices and Radiological Health, told reporters on a conference call.
Tuesday, April 11, 2006
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