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May 15, 2006 -- Bausch & Lomb is recalling its ReNu with MoistureLoc contact lens solution worldwide.
The recall comes in light of a spike in cases of a rare eye infection, Fusarium keratitis, in contact lens users. The recall doesn't include any other ReNu products or generic brands of the contact lens solution.
The FDA and Bausch & Lomb have concluded that ReNu with MoistureLoc's formulation could, in certain situations, make Fusarium keratitis infection more likely.
"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," the FDA's Daniel Schultz, MD, told reporters in a teleconference.
Schultz directs the FDA's Center for Devices and Radiological Health.
Fusarium keratitis can threaten vision. It's caused by Fusarium, a type of fungus.
As of May 9, the CDC had received reports of 106 confirmed cases, 12 possible cases, and 80 cases still under investigation from 32 U.S. states and territories.
Bausch & Lomb's Letter
A letter to customers from Bausch & Lomb Chairman and CEO Ron Zarrella is posted on Bausch & Lomb's web site.
The letter states that "after thousands of tests, there is no evidence of MoistureLoc contamination, tampering or counterfeiting. That leads us to conclude that there may be some aspect of the MoistureLoc formula, when combined with certain environmental factors, lens wear and care practices, and other factors, that might increase the risk of Fusarium infection in rare circumstances."
Zarrella's letter calls removing the product from the market "the right thing to do" and notes that the product will not be reintroduced.
Bausch & Lomb removed its ReNu with MoistureLoc products in the U.S. on April 13.
Complex Scenario
Schultz declined to describe the usage pattern that may up the risk of Fusarium keratitis infection. Zarrella's letter doesn't spell out those scenarios, either.
"There are a large number of factors that need to come into play in order for this to happen. It's not like if you do one thing a certain way, that that's going to cause the problem," Schultz says.
"I think what I'm trying to avoid here is talking about blame as opposed to trying to talk about fixing the problem," Schultz says.
The FDA has been investigating Bausch & Lomb's plant and facilities in Greenville, S.C., where ReNu with MoistureLoc was made, as part of the current Fusarium investigation.
Schultz says the FDA will comment "within the next few days" about "some issues related to good manufacturing practices" at those facilities. But current information shows no link between those issues and the Fusarium cases, Schultz notes.
"At this particular time, based on the information that we have to date, there does not appear to be a direct relationship between those findings and this Fusarium outbreak," Schultz says.
Rare Eye Infections
Fusarium keratitis is rare in contact lens users.
"There is a baseline rate of Fusarium keratitis as well as other forms of keratitis that have been reported on for many years," Schultz says, noting an "apparent spike" in cases seen in users of ReNu with MoistureLoc.
That spike is "not a high percentage problem," given the widespread use of the solution, Schultz notes. "But certainly the consequences are serious and our goal was to try to drop that rate to as low as it could possibly be, recognizing that this is an infection that will occur sporadically," he says.
ReNu with MoistureLoc was introduced in 2004. Schultz says he doesn't know of any formulation changes to the product since then. It can take months or even years for such problems to surface, Schultz says.
"To our best understanding some of these cases did start appearing earlier on in '05 and at this point it's a matter of going back and looking at those cases with the understanding we have now," Schultz says.
SOURCES: Daniel Schultz, MD, director, Center for Devices and Radiological Health, FDA. CDC: "Frequently Asked Questions: General Information about Fusarium Keratitis." Ron Zarrella, Chairman and CEO, Bausch & Lomb: "An Important Message from Bausch & Lomb." News release, FDA.