Report reveals long AE disclosure gap
This article was originally published in The Tan Sheet
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)
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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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