Events

Rappel de Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System)

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-01184-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • 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-01184-1
  • 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 received complaints for the infiniti ultrasound paks related to occlusion of the aspiration line. the investigation identified equipment misalignment during manufacturing which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the infiniti ultrasound paks. alcon is conducting this medical device recall due to the fact that the possibility exists for a loss of aspiration flow and / or occlusions of the aspiration line during surgery which may pose a safety risk to patients.
  • Action
    Alcon is requesting the users to immediately stop further use and segregate the affected lots of INFINITI Ultrasound PAKs. Replacement stock will be issued for units that are returned to Alcon. This action has been closed-out on 18/03/2016.

Device

Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Proc...
  • Modèle / numéro de série
    Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System) Catalogue Number: 8065750280Lot Number: 1628714HARTG number: 141454
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd