Events

Rappel de Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during 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-2015-RN-00751-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-19
  • 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-00751-1
  • 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
    It has been identified that a small percentage of the single-use 23 gauge and 25 gauge valved entry systems have the potential to leak beyond their design specification. leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (iop) in patients. the occurrence of a leaking valved cannula is easily detectable to the user intra-operatively as there will be visible leaking of fluid/saline solution from the entry point of the cannula prior to performing surgery.
  • Action
    To prevent fluctuations of IOP during surgery, surgeons can use the Constellation Vision System’s IOP control feature. Alternatively a plug can be inserted the valve entry system. Alcon is providing standalone plugs to be inserted into affected valve entry systems in the event that unwanted leakage is detected. This action has been closed-out on 17/08/2016.

Device

Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments...
  • Modèle / numéro de série
    Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)Valved Entry Systems sold as standalone and contained within CONSTELLATION TOTALPLUS Paks and Alcon CUSTOM-PAKS Product Numbers:8065 751 585, 8065 751 586, 8065 751 657, 8065 751 658, 8065 751 900, 8065 751 902, 8065 751 908, 8065 751 910ARTG Number: 148011 and 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd