VERY IMPORTANT IF YOU USE AMO COMPLETE MOISTURE PLUS SOULTION!!!
AMO CANADA ANNOUNCES VOLUNTARY RECALL OF
COMPLETE® ALL-IN-ONE MOISTUREPLUS™ CONTACT LENS SOLUTION
(MARKHAM, ON), May 28, 2007 – In response to information received Friday, May 25, 2007,
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, with our parent company Advanced Medical Optics (AMO), AMO Canada is
immediately and voluntarily recalling all lots of Complete® All-In-One MoisturePlus™ contact
lens solution. CDC data was made available to AMO on Friday, May 25th 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® All-In-One MoisturePlusTM contact lens solution. The CDC estimates
a risk of at least seven times greater for those who used Complete® All-In-One MoisturePLUSTM
solution versus those who did not.
While AMO continues to work with the CDC, the U.S. Food and Drug Administration (FDA) and
Health Canada to further assess the data, it is acting with an abundance of caution to voluntarily
recall Complete® All-In-One 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. 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® All-In-One 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 Health Canada to
make sure consumers are aware of the need for proper contact lens disinfection and proper
lens handling. There is no available Canadian data at this time.
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 1-866-492-6019. The company has contacted retailers, customers and
distributors regarding return and replacement instructions. Retailers may also call this number
for more information.
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 forwardlooking
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.amoinc.
com, or by contacting AMO's Investor Relations Department by calling 714-247-8290.
Edelman Public Relations
(416) 979-1120, ext. 231
Edelman Public Relations
(514) 844-6665, ext. 241
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