FDAnews Device Daily Bulletin


April 12, 2006

The FDA released a public health notification, "Fungal Keratitis Infections Related to Contact Lens Use."

The notification is to alert the clinical community to emerging information that the Center for Devices and Radiological Health (CDRH) and Centers for Disease Control and Prevention (CDC) have concerning a recent increase in the number of fungal keratitis cases, a rare but serious fungal infection of the eye, in soft contact lens wearers. The infection, caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

On April 10, CDC reported 109 cases of suspected fungal keratitis in 17 different states. Although the majority of patients have yet to be interviewed, complete data are available for 30 of them. Twenty-eight of the 30 wore soft contact lenses, and preliminary information obtained by CDC from patient interviews indicates that 26 of these patients reported using Bausch & Lomb ReNu brand contact lens solution in the month prior to the infection.

Both the FDA and CDC are investigating this situation. At this time, Bausch and Lomb has agreed to stop shipping the ReNu MoistureLoc brand contact lens solution.

For more information, visit http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html).