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AMO recalls Complete MoisturePlus

This article was originally published in The Tan Sheet

Executive Summary

Advanced Medical Optics recalls the multipurpose contact lens solution after the Centers for Disease Control and Prevention reports a potential link between the product and Acanthamoeba keratitis, a rare eye infection, the Santa Ana, Calif.-based firm announces May 25. AMO says it voluntary initiated a worldwide recall out of "an abundance of caution" in response to reports 46 people had developed AK, 21 of whom used Complete MositurePlus the month prior to symptom onset. AMO adds the current recall is unrelated to reports of the fungal infection Fusarium keratitis that led to Bausch & Lomb's worldwide recall of its ReNu with MoistureLoc contact lens solution in 2006 1("The Tan Sheet," April 17, 2006, p. 5)...

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Report reveals long AE disclosure gap

Abbott Medical Optics waited 15 months to disclose to FDA complaints of serious corneal infections by users of its Complete MoisturePlus contact lens solution, says Washington-based law firm Schmidt & Clark in a June 22 release. The firm says an FDA report obtained under the Freedom of Information Act links the eye infection Acanthamoeba Keratitis to the Irvine, Calif.-based company's contact lens solution. AMO recalled Complete MoisturePlus in May 2007 (1"The Tan Sheet" June 4, 2007)

Contact Lens Care Solutions Should Require “Rubbing” – FDA Panel

All multipurpose contact lens care solutions should include directions for "rubbing" as well as rinsing to help avoid potential eye infections, including solutions previously approved with "no rub" labels on exterior packaging, FDA's Ophthalmic Devices Panel says

AMO recall continues

FDA announces Aug. 1 many consumers may not be aware of Advanced Medical Optics Complete MoisturePlus Multipurpose Contacts Lens Solution recall first issued in May. The firm first announced its recall in May due to a potential link between the solution and Acanthamoeba keratitis, a rare eye infection, in soft contact lens wearers (1"The Tan Sheet" June 4, 2007, In Brief). FDA says several cases of the disease have been reported to the Centers for Disease Control and Prevention after the recall was announced...

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