Events

Rappel de LenSx Laser System (used for femtosecond cataract 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-2014-RN-00424-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-10
  • 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-2014-RN-00424-1
  • 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 addressing reports of unexpected downward motion of the gantry. these reports are associated with systems manufactured with an older style motor/brake assembly. a new style motor/brake assembly (current version) has been used in manufacturing since may 2012. of the 41 reports, contact with the patient's eye or face was reported in three instances. in all of these cases, the contact with patient eye resulting from the unexpected downward gantry motion did not lead to a serious injury or a serious deterioration in state of health.
  • Action
    If customers experience any unexpected gantry movement, they are advised to immediately notify Alcon and stop using the LenSx Laser System. Alcon will replace and install the current motor/brake assembly on any impacted LenSx Laser System manufactured prior to May 2012, including those that have not been previously upgraded.

Device

LenSx Laser System (used for femtosecond cataract surgery)
  • Modèle / numéro de série
    LenSx Laser System (used for femtosecond cataract surgery) Serial numbers: 0611-A020, 0711-A022, 1011-A053, 1011-A060, 0312-A123ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd