Contact solution maker failed to report cases of potentially blinding infection

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.

Source: AP

Related?

Leave a Reply


Protected by Comment Guard Pro