Contact Lens Solution, Eye Fungus Link
Bausch & Lomb Halts Shipment of ReNu Solution Pending Investigation
April 11, 2006 -- A U.S. outbreak of sight-threatening eye fungus is linked
to a contact lens solution, the FDA has announced.
There's no proof that the contact lens solution actually caused the 109 U.S.
cases of an unusual eye fungus infection reported to the CDC. So far, only 30
cases have been fully investigated. All 26 of the infected people who
remembered which contact lens solution they used reported using a Bausch &
Lomb product called ReNu.
Bausch & Lomb has voluntarily stopped shipment of ReNu with MoistureLoc
and an unnamed generic brand that the company also makes. However, the company
has not issued a recall, and ReNu with MoistureLoc remains on drug store
In a news conference yesterday evening, Daniel Schultz, MD, director of the
FDA's Center for Devices and Radiological Health, said that the company's
action is "appropriate and considerate."
Search for Cause
"We do not at this point have information that gives us a direct
cause-and-effect link between any particular product or any particular action
that we can say, 'This is exactly what causes these infections,'" Shultz
said. "The data we have ... associates the use of certain products with some
of these cases in a fairly dramatic fashion. It is that data that ... has caused
Bausch & Lomb to voluntarily stop shipment of a particular product. This is
an ongoing investigation. We expect there will be additional cases that will
provide additional information. The actions we take may change dramatically
over the next few weeks."
The FDA is investigating whether there was fungal contamination at the
Greenville, S.C., plant where the product is made.
"We are evaluating the plant, collecting samples, and testing products.
We will complete that in a matter of days. As new information comes to light,
we will update you," Tim Ulatowski, director of the FDA's Office of
Compliance, said at the news conference.
In a news release, Bausch & Lomb said the company has found no evidence
that its product is contaminated.
"The source of these infections has not been determined," Bausch
& Lomb CEO Ronald L. Zarella said in the news release. "Based on our
extensive testing, analysis, further internal reviews, and communications with
leading experts, the available scientific evidence does not establish any type
of ReNu solution as a cause."
The fungus, fusarium, causes a condition called keratitis. It infects and
damages the cornea. In the current outbreak, eight of the first 26 patients
needed corneal transplants.
The U.S. outbreak began in June 2005, with 109 cases reported as of March
18, 2006. These cases come from 17 U.S. states: California, Connecticut,
Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Missouri, New
Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, and
Of the 30 cases with background information available, 28 cases were in
users of soft contacts. Two patients reported no contact lens use. Some
patients who used the Bausch & Lomb lens solution also used other
solutions, including solutions made by Advanced Medical Optics Inc. and
Fusarium infection is not spread directly from one person to another.
Keratitis is most often seen in soft-contact users who -- against instructions
-- wear their lenses overnight.
Symptoms include unusual redness, eye pain, tearing, discharge, and
sensitivity to light. Soft contact lens users with any of these symptoms should
see a doctor immediately. Doctors must refer patients to an ophthalmologist for
diagnosis, which requires a specimen -- usually corneal scrapings -- for
Topical and oral antifungal medications are the first-line treatment of
fusarium keratitis. Patients who do not respond may need corneal transplants to
preserve their sight.