Events

Rappel de AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Alcon Laboratories Australia Pty Ltd.

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
    RC-2013-RN-00300-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00300-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    This action is an update to the previous ‘urgent recall for product correction' and 'hazard alert' letters issued by alcon in february 2012 and july 2012 for the acrysof cachet phakic lens that described updates to the directions for use (dfu) and advised healthcare professionals of an acute adverse event for endothelial cell loss (ecl). recently alcon conducted a further data analyses of the five-year global study looking at the safety and efficacy of the acrysof cachet phakic lens. whilst the study data showed high efficacy as defined by visual acuity, approximately 1% of implanted lenses showed a risk for accelerated corneal endothelial cell loss (ecl) that led to explantation of the lens. the cause of ecl in individual patients is not well understood and is likely multi-factorial. however, analyses have indicated a trend for higher rates of ecl in:- patients with smaller eyes (those implanted with lens model l12500) - patients self-identified as being asians.
  • Action
    Alcon is revising Directions for Use (DFU) with: - updated clinical data to include results from 5 year clinical studies - strengthen language to require (endothelial cell density (ECD) assessment of every 6 months - provide guidelines for endothelial cell monitoring For patients with the AcrySof CACHET Phakic Lenses already implanted, Alcon is recommending surgeons to remind the patients of the risks associated with undetected ECL and also, discuss the need for strict compliance with the monitoring requirements endothelial cell density ie, monitoring every six months) per the current version of the Directions for Use (DFU). Strict adherence to these requirements by patients will help to timely identify ECL and determine the appropriate treatment plan.

Device

AcrySof CACHET Phakic Lens (Used for the reduction or elimination of myopia)

Manufacturer

Alcon Laboratories Australia Pty Ltd