Events

Rappel de IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carl Zeiss 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-2015-RN-01065-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-03
  • 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-2015-RN-01065-1
  • 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
    These versions of software have a software defect which can result in incorrect iol calculations being presented on screen and in a printout/export in rare cases when a specific non-standard workflow is used. this could lead to order and implantation of iols with wrong lens power and to (correctable) impairment of patient's visual acuity.
  • Action
    To correct the software anomaly users are advised to perform the software update to version 7.5.3 or 7.7.4 using the USB stick by following the instructions provided in customer letter. This action has been closed-out on 31/08/2016.

Device

IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(used for the treatment of axial length, co...
  • Modèle / numéro de série
    IOLMaster 500, software version 7.5.2, 7.7.2 and 7.7.3(used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens) ARTG Number: 128166
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd