Events

Retiro De Equipo (Recall) de TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00

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-2016-RN-01151-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-02
  • 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-2016-RN-01151-1
  • 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
    Abbott has become aware of a small number of tecnis 1-piece iols (two in australia) that may have been mislabelled with the wrong diopter power. this is due to an inspection equipment malfunction during manufacturing. there is potential for lenses to have out of specification diopter or resolution. use of a mislabelled iol could lead to potential unexpected post-operative refractive error.
  • Acción
    Abbott are advising surgeons that if there were no issues identified during routine post-operative follow up, no further action is required regarding the implanted IOL. This action has been closed-out on 12/05/2017.

Device

TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00
  • Modelo / Serial
    TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00 Serial Numbers: 7138311403 and 7139121403ARTG Number: 203780
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd