Events

Alerta De Seguridad para Arcotane 5ml

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Arcadophta SARL.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-12-17
  • Fecha de publicación del evento
    2015-12-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151217.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Arcadophta SARL Arcotane 5ml
  • Manufacturer
    Arcadophta SARL

Manufacturer

Arcadophta SARL