Events

Alerta De Seguridad para Encore 100 Toric Soft Contact Lens

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

¿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
    2012-12-12
  • Fecha de publicación del evento
    2012-12-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121212.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: coopervision encore 100 toric soft contact lens health canada posted a medical device safety alert concerning encore 100 toric soft contact lens, manufactured by coopervision inc. the affected products could be identified by the following lot numbers: 10447500016006, 10519550007006, and 10537500016014. the affected lots contain silicone oil residue levels that exceed the manufacturing process acceptance limits. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 december 2012.

Device

Encore 100 Toric Soft Contact Lens
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CooperVision Encore 100 Toric Soft Contact Lens
  • Manufacturer
    CooperVision Inc

Manufacturer

CooperVision Inc