Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Alcon Laboratories Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00757-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-08-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00757-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd