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