Events

Alerte De Sécurité sur Arcotane 5ml

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Arcadophta SARL.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-12-17
  • Date de publication de l'événement
    2015-12-17
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151217.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: arcadophta sarl arcotane 5ml the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning arcotane 5ml with the lot number 9433347 manufactured by arcadophta sarl. the manufacturer is issuing an urgent recall of arcotane perfluoro-n-octane due to reports of three cases of inexplicable severe vision loss after uneventful retinal detachment surgery during which the perfluoro-n-octane arcotane device has been used. as a conservative measure, the manufacturer has decided to perform a recall of all the lots that are potentially linked to these three cases. according to the alert, at present there is no evidence whether the product arcotane is potentially the cause of the unfortunate vision loss in the three cases reported. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01229-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 december 2015.

Device

Arcotane 5ml
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Arcadophta SARL Arcotane 5ml
  • Manufacturer
    Arcadophta SARL

Manufacturer

Arcadophta SARL