Events

Retiro De Equipo (Recall) de Alcon Labs Accurus Consumables (IIb) - 45150

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 Alcon Laboratories Inc.

¿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
    20167
  • Fecha de inicio del evento
    2016-05-18
  • 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: Alcon Laboratories Australia Pty Ltd (NZ), c/- Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland
  • Causa
    Due to the possible presence of a moulding irregularity found within the aspiration lue may result in a reduction of vacuum within the aspiration line. the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at distal end of the phaco tip.
  • Acción
    Product to be exchanged

Device

Alcon Labs Accurus Consumables (IIb) - 45150
  • Modelo / Serial
    Model: 8065752192, 8065752200, Affected: 1794552H, 1799602H, 1799605H
  • Manufacturer
    Alcon Laboratories Inc

Manufacturer

Alcon Laboratories Inc
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    NZMMDSA