Events

Retiro De Equipo (Recall) de LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation (used during ophthalmic surgical procedure for cataract, retina and cornea)

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-00757-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-21
  • 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-00757-1
  • 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 undertaking a recall for product correction of all lx3 microscope floor stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message (4xx), and/or resulting in illumination failure. alcon will retrofit the cable design on any impacted lx3 microscope floor stands. loss of system functionality during surgery due to issues within the microscope modules or illumination failure will result in the loss of visualisation by the surgeon during the procedure, which can lead to the potential for patient injury. this could include scleral/corneal trauma, intraocular tissue damage, capsule injury, retinal tear/detachment, endothelial cell damage, corneal oedema or intraocular bleeding.
  • Acción
    Alcon is retrofitting all affected devices with a new cable design. Alcon is recommending that if users choose to continue to use the affected devices before the correction has been performed, to ensure an alternative microscope and light source is available. This action has been closed-out on 17/08/2016.

Device

LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microsc...
  • Modelo / Serial
    LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation (used during ophthalmic surgical procedure for cataract, retina and cornea)Product Code: 8065752560ARTG Number: 210550
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd