Events

Alerta De Seguridad para Healon Ophthalmic Viscoelastic Devices

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

¿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
    2017-04-19
  • Fecha de publicación del evento
    2017-04-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170419.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: abbott medical optics healon ophthalmic viscoelastic devices medical device manufacturer, abbott medical optics (amo), has issued a medical device safety alert concerning its healon ophthalmic viscoelastic devices (ovds) [model: healvon (0.85ml), lot number: ub32573; healvon gv (0.85ml); lot number: ub32576]. according to the manufacturer, certain healon ovd solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. use of ovd solutions with glass particles could potentially lead to intraocular injury. the affected users are advised to stop using and remove from the inventory all affected ovd lots. they can continue to use all other lots not affected by this recall. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2017.

Device

Healon Ophthalmic Viscoelastic Devices
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Medical Optics Healon Ophthalmic Viscoelastic Devices
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics