Events

Retiro De Equipo (Recall) de Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract 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-2016-RN-00613-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-09
  • 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-00613-1
  • 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 is conducting a recall for specific lots and catalogue numbers of its centurion fms (fluidics management system) pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. the use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip.There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. there have been no reports of injuries associated with this issue.
  • Acción
    Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected product.

Device

Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the...
  • Modelo / Serial
    Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery)Catalogue Numbers: 8065752180, 8065752181, 8065752200, 8065752201, 8065752917, 8065752918Lot Numbers: 1794105H, 1801726H, 1804659H, 1802316H, 1794157H, 1802311H, 1801714HARTG Number: 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd