Events

Rappel de IOLMaster (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-2013-RN-01070-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-17
  • 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-01070-1
  • 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
    The ulib database delivered with new devices as well as the ulib database offered between march 25 and september 24, 2013 for download contained an erroneous value for one lens. this could lead to the implantation of a lens with a wrong diopter value. specially the a0 constant of the lens amo sensar ar40e is listed as 0.0 in the internal lens database of the iolmaster. the correct value is -2.420. the a0 value is only relevant if the haigis-formula or haigis-l-formula are used. therefore, users that use the amo sensar ar40e and one of the two haigis formulas are affected.
  • Action
    Carl Zeiss is providing users with instructions on how to correct the a0 constant of the AMO Sensar AR40E on the affected IOLMaster systems and instructions on how to download the corrected database.

Device

IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and ...
  • Modèle / numéro de série
    IOLMaster (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