Recall Of Contact Lens Solution
Wellington, New Zealand 26 May , 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® MoisturePlusTM 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® MoisturePlusTM
products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePLUSTM 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® MoisturePlusTM 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® MoisturePlusTM 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.
The company is currently contacting retailers, customers and distributors regarding the recall.
Consumers who believe they are in possession of the recalled product should discontinue use immediately. Any consumer
who is concerned about an eye condition should contact their eye care practitioner in the first instance. Further
detailed information confirming the return process will be forthcoming as soon as it is established. AMO apologies for
any inconvenience caused by this voluntary and precautionary recall, but consumer safety is always our primary concern.
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.
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