Uploaded by LawsuitGuru on May 6, 2008
FDA and CDC are alerting healthcare practitioners and contact lens wearers about an increasing number of reports of a rare but serious eye infection caused by the Fusarium fungus. The infection can cause significant vision loss and require corneal transplant.
Susceptibility to Fusarium infection may be increased by using a Bausch and Lomb product called ReNu with Moisture Loc Contact Lens Solution, and so the company is permanently removing this product from the market. Consumers should stop using ReNu with MoistureLoc immediately.
FDA is advising that when clinicians evaluate a patient with microbial keratitis, they keep in mind that a fungal infection may be involved, and that they consider referring the patient to an eye care professional to obtain a specimen for laboratory analysis. FDA is also asking that clinicians report these infections and the agency will share this information with CDC.
Clinicians should instruct patients to take precautions to prevent contamination of the lenses and the products used to maintain them. This includes washing the hands with soap and water before handling the lenses, keeping the contact lens case clean and replacing it every three to six months, wearing and replacing the lenses according to the prescribed schedule, and following the cleaning and storage guidelines provided by the doctor and the manufacturer. Patients should be warned that if they experience symptoms of infection, they must immediately remove the lenses and consult their doctor.
Additional Information:
FDA MedWatch Safety Alert 2006 - Fungal Keratitis Infections Related to Contact Lens Use. Updated May 31, 2006.
http://www.fda.gov/medwatch/safety/2006/safety06.htm#keratitis
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