Alerta De Seguridad para Biomedics 1 day (55%) toric contact lenses

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

¿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
    2014-03-22
  • Fecha de publicación del evento
    2014-03-22
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: coopervision biomedics 1 day (55%) toric contact lenses it has come to our attention that medical device manufacturer, coopervision, has initiated a field safety corrective action concerning its biomedics 1 day (55%) toric contact lenses. the affected lot number is 10803500560. the manufacturer has identified a single lot of biomedics 1 day (55%) toric contact lenses that have an incorrect lens axis. the labelled specification for the lens axis is 180° instead of the actual 90° axis. the manufacturer advises users to quarantine and return the affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 mar 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CooperVision Biomedics 1 day (55%) toric contact lenses
  • Manufacturer

Manufacturer