Events

Retiro De Equipo (Recall) de Carl Zeiss Master 500

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
    15544
  • Fecha de inicio del evento
    2013-10-21
  • 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
    The ulib database delivered with new devices as well as the ulib database offered between march 25 and sept 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., specifically the a0 constant of the lens amo sensar as40e is listed as 0.0 in the internal lens data base of the iol master. the correct value is -2.420.
  • Acción
    Manufacturer to issue advice regarding use

Device

Carl Zeiss Master 500
  • Modelo / Serial
    Model: 000000-1692-983; 1789-811, 1322-734, 1262-306, 1262-307, 9004-00, 1064-064 and 1134-078, Affected:
  • Manufacturer
    Carl Zeiss Meditec AG

Manufacturer

Carl Zeiss Meditec AG