AMO Announces recall of Complete Moisture Plus
The recall is being initiated because of concerns over eye infections from Acanthamoeba. May 25 2007
Advanced Medical Optics (AMO) has announced a voluntary recall of its Complete MoisturePlus™ contact lens solutions products. The recall is being initiated because of concerns over eye infections from Acanthamoeba a naturally occurring water-borne organism which can contribute to serious corneal infections.
The U.S. Centers for Disease Control and Prevention (CDC) made data available to AMO today showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers 21 of whom reported using Complete® MoisturePlus™ products. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePlus™ solution versus those who did not. This recall is being conducted on a voluntary basis in cooperation with the U.S. Food and Drug Administration (FDA). The incidence of AK infections In the United States has been estimated by COC at approximately one to two cases per million contact lens users. Acanthamoeba is an organism commonly found in water soil sewage systems cooling towers and heating/ventilation/air conditioning (HV AC) systems. AK infections are 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.
Our first priority is protecting patients vision and health. We remain fully committed to providing you with products that meet the highest standards for sterility product effectiveness and patient safety. We are fully cooperating with the CDC and the FDA to meet these goals and sincerely apologize for any inconvenience this action may have caused you as a user of our products. If you are a contact lens wearer and have any of these symptoms you should consult with your eye doctor: 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. Earty 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. If you use Complete® MoisturePlus™ contact lens solutions products please follow these steps:
- Check to ensure that the COMPLETE product you have purchased is a Complete® MoisturePlus™ contact lens solutions product. This recall only pertains to Complete® MoisturePlus™ contact lens solutions products; all other COMPLETE products remain unaffected
- If you are using a Complete® MoisturePlus™ lens solutions product please discontinue use immediately and call 1-888-899-9183
- If you have used a Complete® MoisturePlus™ contact lens solutions product and are experiencing any problems with your eyes consult your eye care practitioner immediately
- Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by call 1-800-347-5005 and to the FDA s MedWatch Program by phone at 1-800-FDA-1088 or 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.
AMO has a 50-year heritage built on high safety and efficacy standards for our products. We are committed to protecting the trust eye care professionals and consumers place in our products and will take all necessary measures to ensure that our products remain safe and effective for the daily disinfecting of all contact lenses.