Updated: May 31, 2006
Original Publication date: April 10, 2006
Dear Healthcare Practitioner:
We are updating the Preliminary Public Health Notification of April 10, 2006, with new 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.
New Information
On May 15, 2006, Bausch and Lomb announced its decision to permanently remove all ReNu with MoistureLoc products worldwide. As previously recommended, consumers should stop using ReNu with MoistureLoc immediately.
On May 19, 2006, the CDC released an MMWR Dispatch updating its on-going multistate investigation into Fusarium keratitis occurring in contact lens wearers. This update can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d519a1.htm. The CDC findings continue to show an increased risk for Fusarium keratitis linked to using Bausch and Lomb’s ReNu with MoistureLoc in the month prior to the onset of infection
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.
At this time, we do not expect our recommendations to change since Bausch and Lomb has permanently removed all ReNu with MoistureLoc worldwide. However, if we identify additional risk factors, or if we have new recommendations for the clinical community or contact lens wearers, we will provide an update.
Recommendations
For healthcare providers:
For contact lens wearers:
FDA Advice to Patients on this topic can be found at http://www.fda.gov/cdrh/medicaldevicesafety/atp/041006-keratitis.html.
Background
In an MMWR Dispatch dated April 10, 2006, CDC stated that it received reports of 109 cases of suspected fungal keratitis in 17 different states. Although the majority of case patients have yet to be interviewed, complete data are available for 30 of them. Twenty-eight of the 30 wore soft contact lenses. Preliminary information obtained by CDC from patient interviews indicates that 26 of these patients remembered which products they used, and that all 26 reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection. Patients reported using a variety of different ReNu types from multiple different product lots. Five of the patients reported using other solutions in addition to the ReNu product. Nine of the patients reported wearing lenses overnight, a known risk factor for microbial keratitis. Eight required corneal transplantation. Strain typing of the organism is ongoing. This document can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d410a1.htm.
CDC and FDA are investigating these case reports. Also, investigations by CDC, state and local health departments, FDA, and manufacturers of contact lens solutions are underway to define specific behaviors or products that place contact lens wearers at increased risk for Fusarium keratitis.
Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.
Background on Microbial Keratitis
Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States. The annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates. In the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62% .
Reporting Adverse Events
FDA and CDC are very interested in gathering information related to fungal keratitis in contact lens users. We encourage you to report these infections to FDA. FDA will be sharing reported information with CDC. You can report directly to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.
Please include the following information (if available) on the MedWatch reporting form:
Getting More Information
Additional information regarding the withdrawal of ReNu with MoistureLoc can be obtained from Bausch and Lomb by calling 1-888-666-2258.
If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.
Sincerely yours,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
Updated May 31, 2006
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