Timeline: Contact solution maker failed to report
Key dates in the outbreak of eye infections linked to Advanced Medical Optics’ Complete MoisturePlus solution:
Feb. 2006- Nov. 2006: AMO receives nine reports involving patients infected with Acanthamoeba keratitis that go unreported.
March 2007: The CDC opens a multistate investigation into unusually high rates of the Acanthamoeba infection, which can result in permanent vision loss or blindness.
May 25, 2007: The CDC links AMO’s Complete MoisturePlus to the outbreak and tells consumers to throw the product away.
May 26, 2007: AMO voluntarily recalls the solution under pressure from regulators at the CDC and the FDA.
May 29, 2007 to June 25, 2007: FDA inspectors arrive to investigate AMO’s Irvine, Calif.-based headquarters. While there the FDA uncovers a series of problems, including the nine unreported complaint forms, which are finally submitted to the FDA.
Summer 2007: FDA officials schedule a meeting to discuss the problems uncovered at AMO’s plant. No disciplinary action is pursued.
The dates within the timeline above are all related to the following article, which you can read by clicking the link below:
Advanced Medical Optics Failed to Report Eye Infections to the FDA
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