Events

Retiro De Equipo (Recall) 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)

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-2013-RN-01070-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-17
  • 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-2013-RN-01070-1
  • 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
    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.
  • Acción
    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 ...
  • Modelo / Serial
    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