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FDA Public Health
Notification:
Fungal Keratitis Infections Related to Contact Lens Use
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:
Advise patients to stop using Bausch and Lomb ReNu with MoistureLoc
products immediately, discard all remaining MoistureLoc solution and use
an alternative cleaning/disinfecting product.
If a patient presents with a microbial keratitis, consider that a fungal
infection may be involved.
Prior to initiating immediate treatment, an eye care professional should
obtain a specimen for laboratory analysis.
Report cases of fungal keratitis in contact lens wearers to FDA as noted
below.
For contact lens wearers:
Stop using Bausch and Lomb ReNu with MoistureLoc products and discard all
remaining MoistureLoc solution including partially used or unopened
bottles.
Consult your eye care professional concerning use of an appropriate
alternative cleaning/disinfecting product.
Consider performing a “rub and rinse” lens cleaning method, rather than a
no rub method, regardless of which cleaning/disinfecting solution used, in
order to minimize the number of germs and reduce the chances of infection.
Continue to follow proper lens care practices:
Wash hands with soap and water, and dry (lint-free method) before handling
lenses.
Wear and replace lenses according to the schedule prescribed by the
doctor.
Follow the specific lens cleaning and storage guidelines from the doctor
and the solution manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience
symptoms such as redness, pain, tearing, increased light sensitivity,
blurry vision, discharge or swelling
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:
● Contact lens solutions trade names and lot
numbers.
● Contact lens type, trade name and mode of
wear (extended or daily wear).
● Patient non-compliance with contact lens
regimen (e.g., overnight wear in daily wear lenses, not cleaning lenses).
● Results of all cultures taken (e.g.,
corneal, conjunctival, contact lens, care solutions, lens case).
● Special patient characteristics, including
whether the patient was immunocompromised (e.g., used topical or systemic
corticosteroids or had diabetes), or had any ocular trauma, surgery, or
chronic eye problem.
● Topical ocular medications used to treat the
patient (including trade names and lot number if available).
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 301-594-2968, or by e-mail at
phann@cdrh.fda.gov. You may also leave a voice mail message at
301-594-0650 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
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