Events

Rappel de KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ellex 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-2013-RN-01254-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • 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-2013-RN-01254-1
  • 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
    The manufacturer, acufocus is aware of reports of some cases involving use of ophthalmic laser applications in eyes containing kamra inlays. during laser treatment, the inlay may absorb the laser and produce heat. this may result in the inlay reducing in size and/or significant thermal damage. in some cases, there were secondary damage to the cornea resulting in scarring. as a result of these case reports, ellex is providing additional warnings and information relative to the application of various ophthalmic procedures with a kamra inlay in situ.
  • Action
    The manufacturer has advised the inlays are not defective and function as intended. The purpose of this notification is to provide additional warnings and information with regard to further treatment to patients implanted with the KARMA inlay.

Device

KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperop...
  • Modèle / numéro de série
    KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))ARTG Number: 182104
  • Manufacturer
    Ellex Australia Pty Ltd

Manufacturer

Ellex Australia Pty Ltd