Events

Alerta De Seguridad para Keratometer and non-invasive pupilometer

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 Gps – Wavelight Gmbh.

¿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
    A1603-100
  • Número del evento
    2014DM-0010914
  • Fecha
    2016-03-11
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=152
  • 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 has received two reports related to the inclusion of arched cuts not in the planned surgeries making use of the verion reference unit equipment to be performed with the lensx team, in other countries worldwide. the situation only arises when the equipment in reference is used to plan an intraocular toricas surgery with different marks than those of alcon, leading to the occurrence of adverse events on the patients.

Device

Keratometer and non-invasive pupilometer
  • Modelo / Serial
    VERION REFERENCE UNIT
  • Descripción del producto
    Keratometer and non-invasive pupilometer, which is additionally used as a planner to determine the surgical plan and determine the appropriate intraocular lens.
  • Manufacturer
    Alcon Gps – Wavelight Gmbh

Manufacturer

Alcon Gps – Wavelight Gmbh
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    NIDFSINVIMA