New
York Bausch Lomb Recall
The well-known contact lens
supply manufacturer, Bausch & Lomb
has recently issued a world-wide
recall of its ReNu with MoistureLoc
contact solution. The recall
resulted from findings by
the FDA of a sharp increase
in the number of fungal eye
infections in the US and
worldwide. As of May 18,
the CDC has received reports
of 130 confirmed cases of Fusarium
keratitis. Among those
cases, 125 wore contact lenses,
and 118 could identify which
contact lens solution(s)
they used.
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Have you suffered
from the affects from Bausch
Lomb Recall ReNu with MoistureLoc? Contact
us for a free consultation
against the Bausch Lomb Recall
of ReNu with MoistureLoc
affecting you today!
Seventy-five (64%) reported
using ReNu with MoistureLoc
along fourteen (12%) reported
using MoistureLoc in combination
with another product, eight
(7%) reported using an unspecified
Bausch & Lomb solution, and
21 (18%) reported using only
products other than MoistureLoc,
from various manufacturers.
While not all reported cases
of fungal eye infection resulted
from use of ReNu with MoistureLoc,
the number of individuals
who used ReNu with MoistureLoc
and suffered fungal eye infections
were disproportionately high.
Since fungal infections among
normal contact lens wearers
is not a common occurrence,
the high incidents of reported
infections in the US and
worldwide gave cause for
alarm.
Bausch & Lomb first stopped
shipment of its ReNu with
MoistureLoc product on April
10, 2006 after the FDA issued
a warning indicating an increase
in fungal eye infections.
On May 15, 2006, a recall
of all its solutions was
issued, asking retail stores
to pull the product from
their shelves. Bausch & Lomb
also issued a statement asking
customers to stop use of
ReNu with MoistureLoc and
switch contact solutions.
While Bausch & Lomb has stated
that they will not reintroduce
ReNu with MoistureLoc, they
have made it clear that none
of their other eye care products
have been affected. Bausch & Lomb’s
other contact lens care products,
such as ReNu MultiPlus, use
a completely different formulation,
and have had a long history
of being extremely safe and
effective. A new program,
Wear & Care, has been launched
by the company in an effort
to provide information and
products to consumers to
help maintain eye health.
Findings have shown that
the fungal infection is caused
by Fusarium keratitis,
an organism that is usually
found in plant and soil material
in tropical and subtropical
regions. At first, contamination
of the contact solution was
suspected, but recent testing
has confirmed that the culprit
is not contamination, but
the formula itself. Inspection
of the company’s Greenville,
South Carolina plant did
reveal 20 FDA health and
safety violations, though
none of these violations
can be directly linked to
the fungal outbreak. Preliminary
results to date from testing
of environmental factors,
raw materials, in-line manufacturing
processes and finished products
have not found that these
factors have contributed
to Fusarium contamination.
Investigations have also
ruled out the possibility
of a counterfeit product
or product tampering. The
most serious violations Bausch & Lomb
has been charged with so
far are its failure to notify
authorities of Fusarium cases
at first, and its failure
to recall the product in
Asia, where large numbers
of cases were first reported.
Because of the formulation
of the contact solution,
which contains three polymers,
specifically of a substance
called alexidine, instead
of the usual one, the fungus
is protected from the disinfectant
that would otherwise kill
it. The polymers were originally
added to the solution to
increase comfort for the
contact lens wearer. Since
the fungus is protected,
with each use of the contact
solution, it would continue
to grow. Infection by Fusarium
keratitis affects the
cornea, which is the clear,
round dome covering the eye’s
iris and pupil. It is usually
a rare infection, but it
is very serious, and if left
untreated, can cause blindness.
Typically, infection by Fusarium
keratitis is caused
by trauma of the eye (where
plant material gets into
the eye), chronic or ongoing
disease of the surface of
the eye, or compromised immune
systems. It is not transmitted
from person to person.
Have you suffered
from the affects from Bausch
Lomb Recall Renu with MoistureLoc? Contact
us for a free consultation
against the Bausch Lomb Recall
of Renu with MoistureLoc
affecting you today!
Symptoms of fungal infection
of the eye by Fusarium
keratitis include eye
pain, eye discomfort, a decrease
in vision, excessive discharge,
and light hypersensitivity.
Sometimes, the infection may
appear as a grayish-white lesion
with feathery borders. Because
many optometrists and ophthalmologists
have never seen this type of
infection, they are ill equipped
to diagnose it. Instead, it
is misdiagnosed as a bacterial
infection, pink eye, or conjunctivitis.
Treatments for these conditions
are ineffective against Fusarium
keratitis. Since it is
often difficult to differentiate
between a bacterial and a fungal
infection, confirmation may
be obtained through a corneal
culture, corneal tissue biopsy,
or confocal microscopy.
Proper diagnosis and treatment are critical to combat
an infection by Fusarium keratitis. If left
untreated, the infection can affect the entire cornea,
and result in blindness. Treatments include prolonged
drug therapy with topical or oral anti-fungals. If
these do not work, surgery is required to remove the
infection, followed by a cornea transplant.
The American Optometric Association has issued a statement
confirming that contact lenses are still safe to use
despite this incident. Hygiene is extremely important
when using contact lenses, particularly the cleanliness
of your hands, contact lenses, and contact lens case.
Any contaminants on these surfaces may get into the
eye upon insertion of the contact lens. The following
six steps are recommended by the American Optometric
Association for proper contact lens care:
1. Always wash your hands before handling contact
lenses.
2. Carefully and regularly clean contact lenses.
3. Store lenses in clean and proper case. Replace
case every three (3) months.
4. Use only cleaning products recommended by your
optometrist.
5. Never re-use old solution
6. Replace contact lenses as prescribed by your doctor.
Lenses should be cleaned immediately upon removal using
the cleaning solution prescribed by your doctor. Fresh
solution should be used each time for cleaning and
storage, and the lens case should be replaced every
three months. Between disinfection cycles, the lens
case should be stored dry. These steps are also effective
against Fusarium keratitis infection.
When not properly cared for, contact lenses have been
associated with eye infections. Common symptoms of
an eye infection include:
- Sudden blurred or fuzzy vision.
- Red/irritated eyes lasting for an unusually long
period of time after removal of the contact lens.
- Pain in and around the eyes.
- Increased sensitivity to light.
- Excessive eye tearing or discharge.
If you experience any of these symptoms, it is important
to consult your doctor immediately.
If you or a family member was taking Bausch & Lomb
ReNu with MoistureLoc and developed a Fusarium
keratitis infection, blindness, sudden blurred
or fuzzy vision, red irritated eyes, pain in the
eyes, excessive sensitivity to light, or excessive
tearing or discharge in your eye, then you may have
a viable legal claim. We have experience handling
mass tort claims and strongly urge you to consult
with an experienced ReNu Lawyer as soon as possible.
Have you suffered from the affects from
Bausch Lomb Recall Renu with MoistureLoc? Contact
us for a free consultation against the Bausch Lomb
Recall of Renu with MoistureLoc affecting you today!
Please call us at 1-866-HELPNY6 (1-866-435-7696) or 212-725-8500 and
speak directly to a Lawyer today.
Michael Gunzburg is a New York Personal Injury
Attorney serving the New York Metropolitan area,
including New York City, Bronx, Brooklyn,
Manhattan, Queens, Staten Island, Nassau, Suffolk,
Westchester, Rockland and Orange County. |
