Events

Alerta De Seguridad para OPTIMEDICA CATALYS PRECISION LASER SYSTEM

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 Optimedical Corporation || Abbott Medical Optics 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
    I1505-201
  • Número del evento
    2014EBC-0011800
  • Fecha
    2015-05-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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 states that medical-referenced devices may present a loss of suction during treatment, in addition to the alteration in the incision mode of cataract, resulting in the same parameters for both eyes, leading to potentially adverse events occurring in patients.

Device

OPTIMEDICA CATALYS PRECISION LASER SYSTEM
  • Modelo / Serial
    OPTIMEDICA CATALYS, lot 44067514, Software Version 3.00.05
  • Descripción del producto
    The equipment OPTIMEDICA CATALYS PRECISION LASER SYSTEM (system laser of precision), with interface of opticaliquida is used to create a capsulotomia anterior of precision and / or the subsequent facofragmentación of the lens, with or without cuts in arc in one or multiple planes of the cornea. The CATALYS precision laser system is indicated for the removal of the lens in patients who are going to undergo cataract surgery.
  • Manufacturer
    Optimedical Corporation || Abbott Medical Optics Inc.

Manufacturer

Optimedical Corporation || Abbott Medical Optics Inc.
  • Source
    NIDFSINVIMA