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U.S. Department of Health and Human Services

Safety

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Advanced Medical Optics Complete MoisturePLUS Multipurpose Contact Lens Solution

Audience: Consumers, ophthalmologists, opticians, other healthcare professionals

[UPDATE 08/01/07] Recall of COMPLETE MoisturePLUS Multi-purpose Contact Lens Solution manufactured by Advanced Medical Optics, Inc. classified by FDA as Class I. See the Recall notice for the list of affected products.

[UPDATE 08/01/07] FDA announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePLUS after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.

[UPDATE 05/31/07] FDA issued a Preliminary Public Health Notification to inform healthcare professionals of a recent increase in reported cases of Acanthamoeba keratitis in soft contact lens wearers. The infections are potentially related to the use of Complete MoisturePLUS Multipurpose Contact Lens Solution.

[Posted 05/29/2007] Advanced Medical Optics and FDA informed healthcare professionals and consumers who wear soft contact lenses of a recall of Complete MoisturePLUS Multi-Purpose Solution. The recall was based on reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention. Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. Symptoms of the infection can be very similar to those of other more common eye infections include eye pain or redness, blurred vision, light sensitivity, the sensation of something in the eye or excessive tearing, but Acanthamoeba is more difficult to treat. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles, and ask their healthcare professional about choosing an appropriate alternative cleaning/disinfecting product. Individuals should seek immediate treatment if they have symptoms of an eye infection as early diagnosis is important for effective treatment.

[August 01, 2007 - Recall Notice - FDA]
[May 31, 2007 - Preliminary Public Health Notification - FDA]
[May 26, 2007 - News Release - FDA]
[May 25, 2007 - News Release - Advanced Medical Optics]