Bausch & Lomb Recalls Lens Solution
Company Pulls ReNu With MoistureLoc Contact Lens Solution Over Eye Fungus Risk
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
"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
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
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
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
Schultz declined to describe the usage pattern that may up the risk of
Fusarium keratitis infection. Zarrella's letter doesn't spell out those
"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
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.