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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Amo is initiating this action due to detection of an inspection equipment malfunction that resulted in a total of 58 distributed lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabelled intraocular lenses. use of a mislabelled intraocular lens could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. intraocular lenses with serial numbers included in the recall letter that have been implanted and resulted in an appropriate post-op refractive outcome are not affected by this action.