In a letter distributed to eye care professionals, Bausch & Lomb
provides details of the final findings of investigation into the
recent outbreak of Fusarium keratitis.
Dear Eye Care Practitioner:
I am very pleased to let you know that I have very recently joined
Bausch & Lomb as Director of Professional Relations. This opportunity
allows me to also continue my 25 year association with the University
of Alabama at Birmingham, now as an adjunct Professor of Optometry,
and to remain in active practice, continuing my history of 28 years
as a clinician colleague.
While I have taken the liberty of starting this letter all about
me, this communication is primarily intended to update you on the
investigation into the cases of Fusarium keratitis associated with
contact lens wear. In recent weeks I have had conversations with
many of our peers and in the process it became clear to me that
there may be some uncertainty as to the outcome of the Fusarium
investigation within minds of the ECP community. With that in mind,
I’ve included highlights below from a recent article regarding the
investigation’s outcome as presented by the Centers for Disease
Control (CDC) and Prevention in The Journal of the American Medical
Association (JAMA).
The August 23, 2006 issue of JAMA contained an article drafted
by a team from the CDC, which outlined the process and findings
of an epidemiological investigation of Fusarium keratitis occurring
among contact lens wearers in the United States. The article titled,
“Multistate Outbreak of Fusarium Keratitis Associated With Use of
a Contact Lens Solution” -- was the CDC’s final report on this matter
and helped provide important information that would educate the
healthcare community regarding this unusual medical event. Go to
http://www.bausch.com/article to order your free copy of the article.
What is noteworthy in this article, as well as other research,
is that the association between the Fusarium outbreak and contact
lens solutions was limited to the MoistureLoc® formula. The U.S.
Food and Drug Administration supported the same conclusion, as do
data published in a separate “case-control” study by the Hong Kong
Centre for Health Protection on June 10, 2006 (Communicable Diseases
Watch, Volume 3, Number 12.). You and your patients can be assured
of the safety and efficacy of Bausch & Lomb ReNu MultiPlus, which
has a proven track record for more than nine years.
The following are some other key findings and observations from
the final CDC article published in JAMA:
As of June 30, 2006, the CDC identified 164 confirmed cases of
Fusarium keratitis in 33 states and one U.S. territory. Of these,
154 reported wearing soft contact lenses. A case-control study was
conducted to delineate factors, which may have contributed to the
disease. The investigation of the clinical events, including the
infecting organism as well as the solution and manufacturing sites,
led the CDC to conclude that contamination of the MoistureLoc product
at the source was not a possible cause.
Results of extensive testing led Bausch & Lomb and the CDC to
conclude that some aspect of the MoistureLoc formula, along with
certain aspects of non-compliance, may increase the relative risk
of rare Fusarium infections in unusual circumstances. The report
states, “It appears that this outbreak may have been caused by a
complex and, as yet, undetermined interaction between MoistureLoc,
Fusarium, and possibly the lens case or contact lens.” The CDC study
also found that patients with the infection were more likely than
controls to store lenses by re-using solution already in their lens
cases. They were also less likely than controls to never clean their
lenses by rubbing.
The report’s conclusions, with which Bausch & Lomb agrees, are
that clinicians should be vigilant in the diagnosis and treatment
of fungal keratitis, and that users of MoistureLoc should discontinue
use of the solution.
I understand that this issue may have caused confusion and concern
among our patients, and that’s why I wanted you to be aware of these
important findings. You can be confident that Bausch & Lomb will
continue to work with eye care practitioners to encourage proper
and effective lens care practices, as part of our ongoing commitment
to the health and safety of our patients.
As always, we at Bausch & Lomb welcome your input.
Sincerely,
Chris Snyder, OD, MS
Director, Professional Relations - Bausch & Lomb Inc