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AMO
Announces Voluntary Recall of CompleteŽ MoisturePlus(TM)
Multipurpose Solution
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 CompleteŽ 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 CompleteŽ MoisturePlus(TM) products. The CDC estimates a risk
of at least seven times greater for those who used CompleteŽ
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 CompleteŽ 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 CompleteŽ 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.
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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
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