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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Due to a secondary processing which occurred during the manufacture of these units an incorrect shelf life was assigned to the product. the incorrect labelled expiry date does not pose a patient safety risk based on data available however in an abundance of caution acufocus is retrieving the two (2) lots of kamra inlays from the market. no other lots of kamra inlays manufactured and distributed by acufocus are affected by this recall action.