Events

Retiro De Equipo (Recall) de Carl Zeiss IOLMaster

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Carl Zeiss Meditec AG.

¿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
    19345
  • Fecha de inicio del evento
    2015-11-09
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Causa
    Due to a software defect iol calculation printouts and exported reports can contain wrong iol power data (mix-up of lens types; calculated iol power does not fit to stated lens type) if a specific and unusual operator sequence is followed and the healthcare provider does not recognize that the second calculation is identical to the first although a different lens type was selected., this could lead to order and implantation of iols with wrong lens power and to (correctable) impairment of patient's visual acuity.
  • Acción
    Software to be upgraded

Device

Carl Zeiss IOLMaster
  • Modelo / Serial
    Model: 000000-1692-983, Affected: , Software version: 7.5.2, 7.7.2 and 7.7.3
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG