Alerta De Seguridad para Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate

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
    2012-11-16
  • Fecha de publicación del evento
    2012-11-16
  • 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: bausch & lomb disposable cannulas provided with amvisc and amvisc plus sodium hyaluronate medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning disposable cannulas with 4-digit lots numbers provided with amvisc and amvisc plus. bausch & lomb, inc. recently identified that some disposable cannulas (with 4-digit lot numbers) provided with the amvisc or amvisc plus ophthalmic viscosurgical device (ovd) are not properly engaging to the luer-lock on the amvisc and amvisc plus sterile glass syringes. the disposable cannulas with 4-digit lot numbers may leak viscoelastic material or detach from the syringe during injection. in rare incidences, detachment has resulted in serious patient injury. this recall is limited to cannulas with 4-digit lot numbers pre-packaged with some amvisc and amvisc plus sodium hyaluronate in sterile glass syringes. it does not include cannulas with 8-digit lot numbers pre-packaged with some amvisc and amvisc plus ovd, nor does it include the amvisc or amvisc plus ovd in the glass syringes themselves. the manufacturer advised the users to discontinue the use of the affected products immediately. the affected products should continue to be refrigerated, but placed in quarantine. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 november 2012.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Medical Device Safety Alert: Bausch & Lomb Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate
  • Manufacturer

Manufacturer