Events

Retiro De Equipo (Recall) de Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)

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-2015-RN-00751-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-19
  • 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-2015-RN-00751-1
  • 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
    It has been identified that a small percentage of the 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. the occurrence of a leaking valved cannula is easily detectable to the user intra-operatively as there will be visible leaking of fluid/saline solution from the entry point of the cannula prior to performing surgery.
  • Acción
    To prevent fluctuations of IOP during surgery, surgeons can use the Constellation Vision System’s IOP control feature. Alternatively a plug can be inserted the valve entry system. Alcon is providing standalone plugs to be inserted into affected valve entry systems in the event that unwanted leakage is detected. This action has been closed-out on 17/08/2016.

Device

Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments...
  • Modelo / Serial
    Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)Valved Entry Systems sold as standalone and contained within CONSTELLATION TOTALPLUS Paks and Alcon CUSTOM-PAKS Product Numbers:8065 751 585, 8065 751 586, 8065 751 657, 8065 751 658, 8065 751 900, 8065 751 902, 8065 751 908, 8065 751 910ARTG Number: 148011 and 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd