Bausch & Lomb Recalls Lens Solution
Company Pulls ReNu With MoistureLoc Contact Lens Solution Over Eye Fungus Risk
Complex Scenario continued...
"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.