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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Technical customer complaints have been received related to the incorrect axis condition on proclear toric (pct) product during the timeframe of 08/20/2012 to 02/17/2014. up to 03/28/2014 a total of 38 technical complaints confirmed as incorrect axis have been associated with the root cause which is related to female insert rotation during the manufacturing process as a result of a damaged loose or missing setscrew that could ultimately result in an incorrect axis condition.