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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Haag-streit received information from four customers regarding a possible deviation in the stimulus luminance of the perimeter octopus 101. one of these devices showed deviations between 1.5db and 2.2db from the tolerance limit and between 2.5db and 3.2db from the specified value respectively (en is012866). long term performance study of the stimulus luminance conducted by haag-streit on the market showed devices deviations from the tolerance limit. the largest of these deviations was l.Odb from the threshold and 2.0db from the specified value respectively. we consider the deviation between 2.5db and 3.2db from the specified value mentioned above as worst case.