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AMO Announces Voluntary Recall of Complete® 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 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
http://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
http://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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