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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Amo quality assurance was notified of a complaint that a patient's left eye was treated with a right eye template. the left eye cataract incisions template was selected as a starting basis for patient treatment planning. from there the right eye/ left eye cataract incisions template buttons were toggled which caused right eye cataract incisions template numbers to be auto populated into the left eye template. this is a software anomaly which translates into a potential incorrect treatment at an occurrence rate higher than established in the risk management file.