FUSARIUM FUNGUS - Fusarium Keratitis Fungus
Fusarium Fungus is normally found in plant material and soil in tropical and subtropical areas. Without eye drop treatment, the infection can scar the cornea causing blindness. Symptoms may include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye.
New Information - Updated: April 21, 2006
This is to provide updated information on the recent increase in reports of a rare but serious fungal infection of the eye in soft contact lens wearers in the U.S. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.
On April 13, 2006, Bausch and Lomb announced that it is withdrawing all ReNu with MoistureLoc products and is recommending that consumers stop using ReNu with MoistureLoc immediately.
Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis in an effort to determine all contributing factors and/or products that place contact lens wearers at increased risk for Fusarium keratitis.
Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution
Contact Lens Solution Eye Fungus may be caused caused by Bausch & Lomb contact lens solution.
Consumers Are Advised to Follow Good Hygiene Practices and Manufacturers' Instructions to Prevent Infection
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight. Some patients have reported a significant loss of vision, resulting in the need for a corneal transplant.
A fungus called Fusarium has been identified as the cause of the reported infections. As of April 9, 2006, 109 cases of suspected Fusarium keratitis are under investigation by CDC and public health authorities in 17 states of the U.S.
"This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."
Bausch and Lomb has informed FDA that they are voluntarily stopping shipment of the ReNu Moisture Loc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.
Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong after multiple reports of the infection among contact lens users there. No other jurisdictions have taken similar action to date.
Fusarium species are normally found in many plants, soil, and tap water. The annual risk of contact lens-related microbial keratitis is estimated in most studies to be between four and 21 per 10,000 patients, depending on whether the lenses are worn only during the day or continuously overnight.
Fungal keratitis can be associated with trauma to the surface of the eye, immunodeficiencies, and contact lens use. Organisms associated with contact lens-related keratitis are usually bacteria rather than fungus, often arising from contamination of lens care products or from contact lens storage cases.
Additional Fungal Keratitis Information
Public Health Notice: www.fda.gov/cdrh/safety/041006-keratitis.htmlCenters for Disease Control MMWR: www.cdc.gov/mmwr/
Contact Lenses and Eye Infections: www.fda.gov/oc/opacom/hottopics/contacts.html
FDA Advice to Patients on this topic can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html.
