SANTA ANA,
Calif.--(BUSINESS WIRE)--May 25, 2007--In
response to information received today from
the U.S. Centers for Disease Control and
Prevention (CDC) regarding eye infections from
Acanthamoeba, a naturally occurring
water-borne organism which can contribute to
serious corneal infections, Advanced Medical
Optics (AMO) (NYSE:EYE) is immediately and
voluntarily recalling its Complete®
MoisturePlus(TM) contact lens solutions. CDC
data was made available to AMO today showing
that it had completed interviews with 46
patients who had developed Acanthamoeba
keratitis (AK) since January 2005. A total of
39 of these patients were soft contact lens
wearers, 21 of whom reported using Complete®
MoisturePlus(TM) products. The CDC estimates a
risk of at least seven times greater for those
who used Complete® MoisturePLUS(TM) solution
versus those who did not.
While AMO
continues to work with the CDC and the U.S.
Food and Drug Administration (FDA) to further
assess the data, it is acting with an
abundance of caution to voluntarily recall
Complete® MoisturePlus(TM) from the market.
There is no evidence to suggest that today's
voluntary recall is related to a product
contamination issue and this does not impact
any of AMO's other contact lens care products,
including our family of hydrogen peroxide
disinfecting solutions. As patient safety is
paramount to AMO, the company is taking
decisive action to stop shipments, recall
product from the marketplace, and encourage
consumers to discontinue the use of AMO
Complete® MoisturePlus(TM) until further
information is available. Given the potential
seriousness of the reported Acanthamoeba
infections, AMO is working in close
partnership with the CDC, the FDA and others
to make sure consumers are aware of the need
for proper contact lens disinfection and
proper lens handling.
Acanthamoeba is
a microorganism commonly found in water, soil,
sewage systems, cooling towers, and
heating/ventilation/air conditioning (HVAC)
systems. Acanthamoeba keratitis (AK) is a
rare, but serious, infection of the cornea. AK
is usually found among individuals who
improperly store/handle/disinfect their lenses
(e.g., use tap water or homemade solutions for
cleaning), swim/use hot tubs/shower while
wearing lenses, come in contact with
contaminated water, have minor damage to their
corneas, or have previous corneal trauma. The
incidence of AK in the United States has been
estimated by CDC at approximately one to two
cases per million contact lens users.
Contact lens
wearers should consult with their eye doctor
if they have any of the following symptoms:
eye pain, eye redness, blurred vision,
sensitivity to light, sensation of something
in the eye, and excessive tearing. The
symptoms, which can last several weeks to
months, are not the same for everybody. Early
in the infection, the symptoms of AK can be
very similar to the symptoms of other more
common eye infections but AK may eventually
cause severe pain and possible vision loss
with some patients requiring a corneal
transplant if untreated.
Consumers who
believe they are in possession of the recalled
product should discontinue use immediately and
call 1-888-899-9183. The company is currently
contacting retailers, customers and
distributors regarding return and replacement
instructions. Reply cards and mailing slips
are being provided for return of product.
Retailers may also call 1-888-899-9183 for
more information.
Please report
any adverse reactions experienced with the use
of this product and/or quality problems to AMO
by calling 1-800-347-5005 and to the FDA's
MedWatch Program by phone at 1-800-FDA-1088,
by fax at 1-800-FDA-0178, by mail at MedWatch,
HF-2, FDA, 5600 Fishers Lane, Rockville, MD
20852-9787, or on the MedWatch Web site at
www.fda.gov/medwatch.
Forward-Looking
Statements
This press
release contains forward-looking statements
about AMO, including those relating to the
product, AMO's investigation, AMO's corrective
actions, and other statements of AMO's current
beliefs. All forward-looking statements in
this press release are based on estimates and
assumptions and represent AMO's judgment only
as of the date of this press release. Actual
results may differ from current expectations
based on a number of factors including but not
limited to AMO's ongoing investigation,
interactions with global regulatory
authorities, and unforeseen health and safety
issues. Therefore, the reader is cautioned not
to rely on these forward-looking statements.
AMO disclaims any intent or obligation to
update these forward-looking statements.
Additional
information concerning these and other risk
factors may be found in previous financial
press releases issued by AMO and AMO's public
periodic filings with the Securities and
Exchange Commission, including the discussion
under the heading "Risk Factors" in
AMO's 2006 Form 10-K filed in March 2007 and
quarterly report on Form 10-Q filed in March
2007. Copies of press releases and additional
information about AMO are available at
www.amo-inc.com, or by contacting AMO's
Investor Relations Department by calling
714-247-8290.
CONTACT:
Advanced Medical Optics
Investors:
Sheree Aronson, 714-247-8290
sheree.aronson@amo-inc.com
Mark Levin, 714-247-8465
Mark.levin@amo-inc.com
or
Media:
Edelman Public Relations
Deborah Kazenelson Deane, 818-395-3043
Deborah.Kazenelson@edelman.com
Jackie Quintanilla, 323-202-1053
jacqueline.quintanilla@edelman.com
SOURCE:
Advanced Medical Optics