Follow-up: Bausch & Lomb has reached the decision to remove its contact-lens solution ReNu from the market because of its association with a fungal infection that can cause blindness. Here is the AP story as reported in the Milwaukee Journal-Sentinel website:
ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc. said Monday it has permanently removed from markets worldwide a contact-lens solution linked by health authorities to an outbreak of rare fungal infections that can cause blindness. Its shares rose nearly 9 percent.
“Bausch & Lomb’s top priority is the safety of our customers, and we want them to have complete confidence in our products,” said the eye-care product maker’s chief executive, Ronald Zarrella.
The Food and Drug Administration said Bausch & Lomb suspects that ReNu with MoistureLoc solution’s unique disinfecting and moisturizing agents “in certain unusual circumstances can increase the risk of Fusarium infection.”
“While FDA is still concluding its scientific evaluations … at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product,” the agency said in a statement.
“There does appear to be an association between the formulation itself as well as certain use patterns in creating this higher-than-normal incidence of these particular infections,” Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in a conference call with reporters.
Schultz did not elaborate on “use patterns” other than to say they combined “somewhat unique circumstances.”
“At this point, our scientific conclusion is pretty clear – that the association is in fact just with the MoistureLoc solution,” Schultz said.
The Centers for Disease Control and Prevention said Friday that the number of confirmed cases of Fusarium keratitis in the United States has climbed to 122, most of them contact-lens wearers who reported using Bausch & Lomb’s newest cleaner, which was introduced in late 2004.