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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The advisory notice is associated with the visx excimer laser system (licence 2145). this action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure in the ac power distribution printed circuit board (pcb) in the visx excimer laser system specifically models star s2 star s3 star s4 custom vss and star s4 ir.