Events

Retiro De Equipo (Recall) de Arcadophta SARL– Arcotane 5ml

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-01229-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-12-15
  • 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-01229-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, arcadophta sarl, is issuing this urgent recall of arcotane perfluoro-n-octane due to reports of three (3) cases of inexplicable severe vision loss after uneventful retinal detachment surgery during which the perfluoro-n-octane arcotane device has been used. at present there is no evidence whether the product arcotane is potentially the cause of the unfortunate vision loss in the three (3) cases reported, however as a conservative measure, arcadophta has decided to perform a recall of all the lots that are potentially linked to these three (3) cases.
  • Acción
    DTA is advising users to review inventory and quarantine any of the affected lot for return to DTA. This action has been closed-out on 05/09/2016.

Device

Arcadophta SARL– Arcotane 5ml

Manufacturer

Device Technologies Australia Pty Ltd