Events

Retiro De Equipo (Recall) de Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Alcon Laboratories 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-2014-RN-01184-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-13
  • 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-2014-RN-01184-1
  • 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
    Alcon received complaints for the infiniti ultrasound paks related to occlusion of the aspiration line. the investigation identified equipment misalignment during manufacturing which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the infiniti ultrasound paks. alcon is conducting this medical device recall due to the fact that the possibility exists for a loss of aspiration flow and / or occlusions of the aspiration line during surgery which may pose a safety risk to patients.
  • Acción
    Alcon is requesting the users to immediately stop further use and segregate the affected lots of INFINITI Ultrasound PAKs. Replacement stock will be issued for units that are returned to Alcon. This action has been closed-out on 18/03/2016.

Device

Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Proc...
  • Modelo / Serial
    Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System) Catalogue Number: 8065750280Lot Number: 1628714HARTG number: 141454
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd