Events

Alerta De Seguridad para SH-System Monatslinsen contact lenses

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 4Care AG.

¿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
    2011-12-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111206a.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
    Field safety notice: 4care ag’s sh-system monatslinsen contact lenses the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on 4care ag’s monthly contact lenses “sh-system monatslinsen” due to the presence of small parts of silicone oil in some lots of the products. it may lead to blurry view or a foreign body sensation in the eye. sometimes it can lead to eye pain. 4 care ag is conducting a recall of the product.For details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

SH-System Monatslinsen contact lenses
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 4Care AG's SH-System Monatslinsen contact lenses
  • Manufacturer
    4Care AG

Manufacturer

4Care AG
  • Source
    DH