FDA Reclassifies AMO Complete MoisturePlus Recall as Class I

[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

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

On August 1, 2007 the U.S. Food & Drug Administration 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.

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