Events

Alerta De Seguridad para Ophthalmic Viscosurgical Device Healon EndoCoat and Healon Duet Dual

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 Amo Ireland. || 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
    I1411-479
  • Número del evento
    2013DM-0010182
  • Fecha
    2014-11-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 it has received reports of incidents in which the grip with the fingers of the devices dislodged while the user presses the plunger of the syringe, if the grip groove is dislodged, the hand of the surgeon could accidentally move the cannula, resulting in a trauma in the patient's eye, this situation can be dislodged if the user does not follow the instructions for use (dfu), leading to potential adverse events occurring on the patient.

Device

Ophthalmic Viscosurgical Device Healon EndoCoat and Healon Duet Dual
  • Modelo / Serial
  • Descripción del producto
    The HEALON ENDOCOAT ophthalmic visco-surgical device is used in anterior-calculus-soft surgical procedures, including: decatarata surgery with an intraocular lens, cataract surgery without an intraocular lens, implantation of intraocular-secondary lens.
  • Manufacturer
    Amo Ireland. || Abbott Medical Optics Inc.

Manufacturer

Amo Ireland. || Abbott Medical Optics Inc.