Events

Rappel de TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AMO CANADA COMPANY.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    98332
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-08-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
  • Modèle / numéro de série
    Model Catalog: PCB00 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: AR40E (Lot serial: 2015871503); Model Catalog: ZXR00 (Lot serial: 8496921508); Model Catalog: ZCB00 (Lot serial: 5152641501); Model Catalog: ZCB00 (Lot serial: 5152541501); Model Catalog: ZCB00 (Lot serial: 5152621501); Model Catalog: ZCB00 (Lot serial: 5152481501); Model Catalog: ZCB00 (Lot serial: 5152561501); Model Catalog: ZCB00 (Lot serial: 5152601501); Model Catalog: ZCB00 (Lot serial: 5152501501); Model Catalog: ZCB00 (Lot serial: 5152461501); Model Catalog: ZCB00 (Lot serial: 5152581501); Model Catalog: ZCB00 (Lot serial: 5152661501)
  • Description du dispositif
    TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM;SENSAR FOLDABLE IOL WITH OPTIEDGE;TECNIS SYMFONY EXTENDED RANGE OF VISION IOL;TECNIS 1-PIECE ACRYLIC ASPHERIC IOL
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY