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 an increase of opacification complaints oculentis initiated a study to investigate the sporadic late postoperative opacification of lentis iols (completed august 30 2017). the results of our study have indicated that surface calcification could possibly be the result of phosphate remnants originating from a phosphate containing detergent previously used in the cleaning process of the iol from january 2012 -may 2015.