Bausch & Lomb Recalls Lens Solution
Company Pulls ReNu With MoistureLoc Contact Lens Solution Over Eye Fungus Risk
WebMD News Archive
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
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
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.