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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Acufocus is aware of reports of some cases this device being used in eyes containing karma inlays. this notice is to update customers on ophthalmic procedures with a kamra inlay in situ.