April 11, 2006
Bausch & Lomb to Temporarily Suspend Shipments of ReNu with MoistureLoc
in the U.S.
Bausch & Lomb to Continue Support of Multi-Center Surveillance
Programs with CDC and Wilmer Eye Institute
Patient Compliance Important, make sure patients follow AOA recommendations
for clean and safe contact lenses
Dear Eye Care Professional:
As part of our ongoing efforts to investigate and communicate about
cases of fungal keratitis in parts of Asia and in the U.S., we want
to ensure that you have the latest information. At Bausch &
Lomb, our highest priority is the ocular health and safety of your
patients; if you have comments, questions or suggestions following
your review of this communication, please contact us per the details
at the end of this letter.
As you may have heard, reports of an unusual incidence of Fusarium
keratitis among contact lens wearers first came from health authorities
in Singapore, Hong Kong and Malaysia. Because these infections are
rare, there is now a heightened level of awareness and surveillance
in other countries, including the U.S. This is not an infection
that has been tracked closely in the past, so the actual number
of cases, and the deviation from ?normal? background levels of infection,
is unknown.
Shipments of ReNu with MoistureLoc are Temporarily Suspended in
U.S.
The U.S. Centers for Disease Control has reported an analysis of
the cases of 28 contact lens users, 26 of whom remembered what lens
care product they used. Twenty-one reported using ReNu brand products
and five reported using a combination of ReNu and products manufactured
by other companies. There is an apparent disproportionate representation
of ReNu with Moisture Loc in the CDC data, and so we have voluntarily
suspended U.S. shipments of that product while the investigation
continues. Again, no cause has been established. This action is
based simply on the statistical analysis of the small number of
cases which have been reviewed to date. Both the CDC and the FDA
have emphasized that no causal relationship between ReNu with MoistureLoc
and these incidences of fungal keratitis have been found. However,
we at Bausch & Lomb believe that every effort should be made
in assisting with this investigation in order to quickly identify
the root cause of these infections. As such, we have voluntarily
suspended the shipments of ReNu with MoistureLoc here in the U.S.,
pending further investigation.
Bausch & Lomb?s FDA-licensed manufacturing facility in South
Carolina has been extensively monitored. In addition, Bausch &
Lomb does extensive, ongoing testing of its products and has conducted
additional tests to ensure the biocidal efficacy of our lens care
regimens against Fusarium and a host of other ocular pathogens.
For example, product from the lots of ReNu® with MoistureLoc®
multi-purpose solution that were identified as being used by patients
in Singapore, Hong Kong and the U.S. were tested and shown to be
effective in killing both standard strains and clinical isolates
of the fungus. Product samples collected from these markets were
tested with a full panel of biocidal challenge organisms and chemical
testing, including testing of component materials, has been performed.
Again, testing indicated that the samples were within specification
and highly effective in killing bacteria and fungi. We are pleased
to be working with the FDA and the CDC in this matter, and are pleased
that the FDA has publicly viewed our decision to suspend shipment
as a responsible step, notwithstanding the lack of causal connection.
Multi-Center Surveillance Programs with CDC and Wilmer Eye Institute
As reported by the U.S. Centers for Disease Control and Prevention,
an ongoing investigation by CDC, state and local health departments
and the Food and Drug Administration is under way to determine whether
this cluster represents an increase of Fusarium keratitis infections
and to determine the association, if any, of these cases with any
product. Epidemiologic and laboratory studies will help define specific
activities, hygiene practices, or products that place persons at
increased risk for Fusarium keratitis.
We feel we must continue to thoroughly investigate the root cause
of reported cases of Fusarium infections. As such, we are working
closely with the health authorities in Asia, the U.S. Centers for
Disease Control and Prevention and the Wilmer Eye Institute of Johns
Hopkins University to implement a multi-center surveillance program
to establish the actual incidence and to try to determine the root
cause of the infection. Bausch & Lomb is also working with independent
experts in microbiology to collect and culture clinical isolates
of Fusarium from patient samples to identify the genetic make-up
of the organisms, and to determine if they represent an uncommon
variant of the fungus.
Compliance and Hygiene Messages Must Be Reinforced
We encourage the profession to urge patients to follow the American
Optometric Association?s top 5 recommendations for clean and safe
contact lenses. As a reminder, those recommendations are:
Carefully and regularly clean contact lenses, as directed by an
optometrist and the patient information included with lens care
products.
Rub the contact lenses with fingers and rinse thoroughly before
soaking the lenses overnight in enough multi-purpose solution to
completely cover the lens.
Use the proper products to clean and disinfect contact lenses as
recommended by your optometrist. Remember that saline solutions
and rewetting drops are not designed to disinfect lenses.
Store lenses in the proper case and replace the lens storage case
every three months. Clean the contact lens case after each use and
keep the case open and dry between cleanings.
Only fresh solution should be used to clean and disinfect contact
lenses. Never re-use old solution. Contact lens solution must be
changed every day, even if the lenses are not used daily.
We will also emphasize in our consumer materials that contact lenses
are prescription products and therefore should never be shared between
friends. Lenses always should be worn according to the wearing schedule
prescribed by their doctor. Never try to stretch the longevity of
your lenses. Before handling your lenses, patients should always
thoroughly wash their hands with soap and water and dry them with
a lint free towel. In addition we would like to familiarize you
with new and existing tools to help you reinforce these patient
compliance messages, which are available through your Bausch &
Lomb representative:
- Wear-and-Care video available on DVD and VHS. These can either
be run in your office or given (DVD only) to your patients as a
reminder of proper care. Patients can also be directed to view this
tool on the web at www.bausch.com/wearandcare
- Wear-and-Care brochure ? which reinforces proper care and cleaning
steps.
- A countertop fitting mat ? that features illustrative and written
instruction for the proper wearing and caring of your patients?
contact lenses.
- Free lens cases and in-office contact lens materials that provide
wearing and caring content.
Beyond the aforementioned tools, we are also adding programs. We
are:
- Updating all trade and care kit language to emphasize the need
to wear and care for lenses properly. As part of this program, we
will change the name of our ?Great Start Sample Kit? to ?Healthy
Start Sample Kit?.
- Changing the recommendation for replacing lens cases from once
every three months to replacing them monthly. This change will occur
on all lens case and contact lens solution packaging.
- Working with leaders in the eye health industry to develop other
programs that can be launched over the coming months to help emphasize
the importance of lens and lens care regimen compliance direct to
patients to ensure they continue to enjoy safe and comfortable contact
lens wearing experiences.
Finally, as clinicians, we remind you of the further advice of
the CDC:
Clinicians evaluating contact lens users with signs or symptoms
of keratitis, such as unusual redness, eye pain, tearing, discharge,
or sensitivity to light, should consider fungal keratitis. Clinicians
should consider obtaining clinical specimens (e.g., corneal scrapings)
for culture before initiating treatment.
We share your concern about this potential threat to eye health,
and are doing all we can to help determine the cause and extent
of infections caused by Fusarium. We will continue to keep you updated
as more information becomes available. Your input is welcome ? you
can reach us in the following ways:
Email: eyehealth@bausch.com
Phone: 1-800-828-9030 ? Push #3 for a technical fitting consultant.
Mail: Bausch & Lomb, Inc.
1400 North Goodman Street
Attn: Eye Health Program
Rochester, NY 14609
Sincerely,
Robert J. Moore
General Manager ? U.S. Vision Care
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