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CDC Final Report on Fusarium Issue Published in Journal
of the American Medical Association -- August 23, 2006
JAMA Articles (Note: Access to JAMA articles
requires registration and payment)
Throughout the investigation, FDA has worked very closely with
CDC to assure that all known cases and key information were
shared to the extent that our different missions and regulatory
constraints allow to promote the most thorough and expeditious
investigation possible and to take the necessary steps to protect
the public health.
The Fusarium incident has prompted FDA to re-evaluate current
testing methods. FDA is part of a working group formed
in March 2006 by the International Standards Organization that
will look at current testing methods. While we are continuing
to evaluate testing results related to the current Fusarium
incident with ReNu MoistureLoc as these results become available,
we will determine what specific recommendations to propose to
modify testing methodology for multipurpose solutions, once
the working group issues finalized their recommendations.
FDA Statement
on Preliminary Bausch & Lomb Inspection Findings (May
16, 2006)
FDA Statement--Bausch & Lomb
Global Recall of ReNu with MoistureLoc Contact Lens Cleaning
Solution (May 15, 2006)
Update on Serious Eye Infections Associated With Soft
Contact Lens Use and Contact Lens Solution -- May 5, 2006
As reported in the MMWR, patients with confirmed cases of Fusarium keratitis
have reported using various contact lens cleaning solutions
including various types of ReNu products and generics. We continue
to confirm reported cases associated with products other than
ReNu with MoistureLoc. Our interest in the MoistureLoc
product is based on the disproportionate number of case of Fusarium keratitis
associated with ReNu with Moisture Loc compared to the overall
product market share. The trends of reported cases involving
various contact lens solutions other than MoistureLoc have remained
consistent throughout our investigation.
FDA continues to work with the CDC to investigate
the Fusarium keratitis
infections and will determine whether or not further action
needs to be taken. While the investigation is ongoing, FDA will
continue to update the public health notice and advice to consumers
as needed. In addition, the FDA and CDC are urgently advising
consumers to consult your doctor immediately if you experience
symptoms such as redness, pain, tearing, increased light sensitivity,
blurry vision, discharge or swelling. In addition, the Centers
for Disease Control and Prevention (CDC) released further clarification
on the information on the multi-state outbreak of Fusarium keratitis
that may be associated with contact lens use. (CDC
press release: http://www.cdc.gov/od/oc/media/pressrel/r060505.htm).
Update on Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution -- April 21, 2006
Bausch & Lomb has recommended that consumers stop using ReNu with MoistureLoc immediately and discard all remaining MoistureLoc solution including partially used or opened bottles. 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 may place contact lens wearers at increased risk for Fusarium keratitis. As part of this ongoing investigation, we are continuing joint inspections of the Bausch & Lomb plant and facilities in Greenville, SC including testing of products, environmental factors and raw materials. Because of the nature of the organism (Fusarium), extensive microbiological testing is being conducted and may take up to one month to fully analyze. We are committed to continuing a comprehensive approach aimed at determining the cause of these infections and will provide regular updates on our activities through preliminary public health notices issued through FDA.
Update on Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution -- April 13, 2006
Bausch & Lomb today asked U.S. retailers to remove ReNu® with MoistureLoc® from their shelves temporarily, and recommended that consumers switch to another lens care solution for the time being, until the investigation of reports of fungal keratitis infections among contact lens wearers in the United States is concluded. The company initiated the voluntary market withdrawal in order to eliminate any confusion among contact lens wearers about what to do while the investigation is ongoing. Today’s action does not apply to other Bausch & Lomb products or to ReNu with MoistureLoc manufactured at factories outside the United States. Complete Bausch & Lomb press release.
FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Solution (April 14, 2006)
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 of rare but serious fungal infections in the
eye that can cause permanent blindness. Some patients have reported a significant
loss of vision, resulting in the need for a corneal transplant.
Clinicians who evaluate patients with microbial keratitis should consider
that a fungal infection may be involved and refer the patient to an eye care professional,
if appropriate, to obtain a specimen for laboratory analysis.
In addition, the FDA and CDC are urgently advising consumers to take precautions
to prevent contamination of the lenses and the products used to maintain them.
These preventive practices include:
- 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.
In addition, regardless of which cleaning/disinfecting solution used, wearers
may want to consider performing a "rub and rinse" lens cleaning method,
rather than a no-rub method, in order to minimize the number of germs and reduce
the chances of infection.
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