Events

Rappel de VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)

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-2016-RN-00255-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • 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-2016-RN-00255-1
  • 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 has received reports concerning the inclusion of unplanned arcuate incisions on printed, saved (.Pdf) or exported surgical plans. this situation only occurs when the verion reference unit (vision planner) is used to create a surgical plan for non-alcon toric intraocular lenses (iols) that is used with the alcon verion digital marker lensx laser system. surgical plans for alcon toric iols as well as all spherical iol regardless of brand are not affected. these unintentional surgical plan arcuates can occur if the deactivated ‘iol 100% – ri 0%’ slider bar is unintentionally activated by the user in the planning software. this directs the software to include the addition of arcuates for the surgical procedure and can only be seen on the exported, saved (.Pdf) or printed surgical plans. if the additional arcuates are performed this may lead to an astigmatism overcorrection resulting in reduced unaided visual acuity.
  • Action
    Alcon is providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent fix.

Device

VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning...
  • Modèle / numéro de série
    VERION Reference Unit (Vision Planner) - used with the Alcon LenSx Laser System (Surgery planning system for ophthalmic surgery)Catalogue Number: 8065998240ARTG Number: 214732
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd