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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The directions for use will be revised to include the following information: -clarification that the acrysof cachet phakic lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d. -additional information regarding the risk of early acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient. -clarification on the frequency of monitoring for ecl by specular microscopy. the new recommendation is applicable for post-operative follow-up at one month three months and six months and then at six-month intervals in collaboration with the treating physician. -data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm2 in the clinical studies.
Model Catalog: L14000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L13000 (Lot serial: ALL LOTS); Model Catalog: L12500 (Lot serial: ALL LOTS)