Events

Retiro De Equipo (Recall) de Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AMO Australia Pty Ltd.

¿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
    RC-2017-RN-00524-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-26
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00524-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    There is the possibility that due to a packaging error, 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package. use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.
  • Acción
    AMO Australia is advising users to immediately stop using and remove from their inventory all affected lots of the Vitrectomy Cutter. AMO will arrange for return of affected product and replacement.

Device

Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve
  • Modelo / Serial
    Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation SleevePart Number: NGP0020Lot Number: CA0618025GA Vitrectomy CutterPart Number: NGP0025Lot Number: CA06182ARTG Number: 93352
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd