Events

Alerta De Seguridad para Surgical System of Facofragmentation - CENTURION

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Alcon Laboratories 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
  • ID del evento
    R1605-209
  • Número del evento
    2013EBC-0010838
  • Fecha
    2016-05-05
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that due to the possible presence of irregularities in the shape of the suction cups, which can result in a reduction of the vacuum inside the suction line, which does not allow to reach the maximum programmed vacuum, leading to adverse events on patients. and delays in the procedures.

Device

Surgical System of Facofragmentation - CENTURION
  • Modelo / Serial
    Concerning your Packs for CENTURION FMS (fluid management system), reference 8065752182, lots || 1794545H and 1794549H
  • Descripción del producto
    Designed for use by physicians in phacoemulsification, separation and elimination of cataracts, removal of residual cortical material and epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation and intraocular lens injection.
  • Manufacturer
    Alcon Laboratories Inc.

Manufacturer

Alcon Laboratories Inc.
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    NIDFSINVIMA