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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This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user. in the current workflow a user can select to delete a record(s). when that selection is made a confirmation box is presented asking the user if they want to delete the record(s). the user can then either left click on "ok" or press the "enter" key to confirm the action. currently this confirmation defaults to "ok" or "yes". in this workflow a user could inadvertently hit the "enter" key which would delete the images or procedures. once these images or procedures are deleted they are lost permanently with no recovery.
Model Catalog: MERGE EYE STATION (Lot serial: 11.3.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.1); Model Catalog: MERGE EYE STATION (Lot serial: 10.6); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.1); Model Catalog: MERGE EYE STATION (Lot serial: 11.5); Model Catalog: MERGE EYE STATION (Lot serial: 11.3.2); Model Catalog: MERGE EYE STATION (Lot serial: 11.4); Model Catalog: MERGE EYE STATION (Lot serial: 11.6.0); Model Catalog: MERGE EYE STATION (Lot serial: 11.2.0)