Events

Rappel de ACRYSOF CACHET PHAKIC LENS

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

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
    108435
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-04-02
  • 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
    This notice is being provided to update the healthcare professionals on the actions alcon is taking concerning the alcon acrysof cachet phakic lens. this is further update to the communications alcon issued in february 2012 and july 2012 where they described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). alcon is developing a plan of action to ensure that physicians have the information they need to appropriately treat and monitor patients and that patients can make an informed choice about their treatment. while this is taking place and until further guidance is issued alcon is voluntarily suspending shipment of the acrysof cachet phakic lens from their facilities. the study data showed high efficacy as defined by visual acuity but a small subset of patients (approximately 1% of implanted lenses to date) showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the company is currently discussing a plan of action with the health authorities.

Device

ACRYSOF CACHET PHAKIC LENS
  • Modèle / numéro de série
    Model Catalog: L13000 (Lot serial: ALL LOTS); Model Catalog: L13500 (Lot serial: ALL LOTS); Model Catalog: L14000 (Lot serial: ALL LOTS); Model Catalog: L12500 (Lot serial: ALL LOTS)
  • Description du dispositif
    ACRYSOF CACHET PHAKIC LENS
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    HC