Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Abbott medical optics inc. initiated this event after becoming aware of a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 micrometres or deeper) created using the femtosecond laser system. this discrepancy between the user-set depth of corneal tissue incision and the actual depth of those incisions was discovered during an engineering investigation conducted prior to the launch outside the united states of a new indication for arcuate incision procedures. the engineering investigation was not initiated due to the receipt of a complaint.