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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Alcon received complaints for the infiniti ultrasound paks related to occlusion of the aspiration line. the quality review processes showed an equipment misalignment which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the infiniti ultrasound paks. this recall is being conducting due to the fact that the possibility exists for a loss of aspiration performance during surgery which may pose a safety risk to patients.