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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Potential sterility failure of the paper pouch (supplied to rayner by an external company) that surrounds the intraocular lens blister tray. a failed pouch seal may cause the patient permanent serious injury and may cause severe infection and/or contribute to the development of toxic anterior segment syndrome (tass). tass can cause serious damage to intraocular tissues resulting in vision loss.