Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01065-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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