Contact Lens Solution, Eye Fungus Link
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 shelves.
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 Vermont.
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 Alcon.
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 culture.
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.