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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Alcon is voluntarily discontinuing the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. patients with the cachet phakic lens should continue with the ongoing monitoring and evaluation outlined in the current directions for use( dfu). in cases where an explant is warranted in accordance with the criteria set out in the attached dfu alcon will work with the treating ophthalmologist to ensure that the affected patients receive an explant without incurring out-of-pocket costs.
Model Catalog: L12500 (Lot serial: all lots); Model Catalog: L13000 (Lot serial: all lots); Model Catalog: L13500 (Lot serial: all lots); Model Catalog: L14000 (Lot serial: all lots)