Events

Retiro De Equipo (Recall) de Alcon Constellation Custom Paks

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 Surgical 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
    19003
  • Fecha de inicio del evento
    2015-08-27
  • 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
    The manufacturer advises that specific lots of its single-use 23 gauge and 25 gauge valved entry systems have the potential to leak beyond their design specification. leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (iop) in patients.
  • Acción
    Manufacturer to issue advice regarding use

Device

Alcon Constellation Custom Paks
  • Modelo / Serial
    Model: Selected packs, Affected: Selected lots
  • Manufacturer
    Alcon Surgical Inc

Manufacturer

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