Events

Retiro De Equipo (Recall) de ACCURUS Vitrectomy probes

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-00481-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-06-05
  • 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-00481-1
  • 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 has identified an insufficient seal on the outside packaging that could potentially affect the sterility of the product. the use of non-sterile vitrectomy probes in surgery has the potential to result in patient infection or inflammation and may lead to serious injury and sequelae, including loss of vision.. at this time, no adverse events or complaints have been confirmed related to the accurus vitrectomy probe lots impacted by this issue. regular post-operative patient follow-up may enable the surgeon to detect early potential abnormal inflammatory reaction and/or infection, which may reduce the severity of the ensuing event.
  • Acción
    Customers are advised to immediately stop further use of the affected lots and to segregate them to ensure that they are not used. Alcon will provide reimbursement for all returned product This action has been closed-out on 9/08/2016.

Device

ACCURUS Vitrectomy probes
  • Modelo / Serial
    ACCURUS Vitrectomy probesACCURUS 23GA Standalone Vitreous ProbeCatalog # 8065750821Lot number: 14017912XAnterior ACCURUS® Probe with infusion needle Catalog # 8065803650Lot numbers: 14010430X, 140174S1X, 14010430X, 14017451XARTG Numbers 140947 and 145666
  • Clasificación del producto
    Ophthalmic Devices
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd