Alerta De Seguridad para Soflens 59, lot W12010319

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

¿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
    2011-09-28
  • 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
    Voluntary product recall: bausch & lomb soflens 59, lot w12010319 medical device manufacturer, bausch & lomb, is conducting a voluntary product recall for soflens 29 lot w 12010319 due to incorrect expiration date on secondary carton. 1000 units (2 packs) of soflens 59 lot w12010319, expiration date 2016-02 were repacked at the warehouse for distribution exclusively to thailand.  during the process, an overlabel with the incorrect expiration date 2106-02 was applied to the product. therefore, lenses could be expired but still be available in the supply chain due to the incorrect expiration date on the label.  according to the supplier, the affected batch is only distributed in thailand and hong kong is not affected. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bausch & Lomb Soflens 59, lot W12010319
  • Manufacturer

Manufacturer