Events

Rappel de Arcadophta SARL– Arcotane 5ml

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-01229-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-15
  • 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-01229-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, arcadophta sarl, is issuing this urgent recall of arcotane perfluoro-n-octane due to reports of three (3) cases of inexplicable severe vision loss after uneventful retinal detachment surgery during which the perfluoro-n-octane arcotane device has been used. at present there is no evidence whether the product arcotane is potentially the cause of the unfortunate vision loss in the three (3) cases reported, however as a conservative measure, arcadophta has decided to perform a recall of all the lots that are potentially linked to these three (3) cases.
  • Action
    DTA is advising users to review inventory and quarantine any of the affected lot for return to DTA. This action has been closed-out on 05/09/2016.

Device

Arcadophta SARL– Arcotane 5ml

Manufacturer

Device Technologies Australia Pty Ltd