Events

Retiro De Equipo (Recall) de CONSTELLATION PNEUMATIC HANDPIECE DSP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ALCON CANADA 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
    25455
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Alcon received complaints for the constellation pneumatic handpiece dsp product number 725.01 related to the tip dislodging from the hand piece during the surgical procedure. if the tip becomes dislodged from the hand piece while in the eye a patient injury may occur. the constellation pneumatic handpiece and tips are unlikely to cause injury when tips are attached in accord with the directions for use. however review of the complaint cases to date indicates potential for isolated instances of detachment to occur if the tip has not been correctly attached. therefore alcon has decided to halt manufacturing of this product and remove any remaining lots from the market.

Device

CONSTELLATION PNEUMATIC HANDPIECE DSP
  • Modelo / Serial
    Model Catalog: 725.01 (Lot serial: F85110); Model Catalog: 725.01 (Lot serial: F85466)
  • Descripción del producto
    CONSTELLATION PNEUMATIC HANDPIECE DSP
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    HC