Events

Alerta De Seguridad para HEALON Sterile Viscoelastic Solution

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 Uppsala Ab.

¿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
    R1705-183
  • Número del evento
    2010DM-0006480
  • Fecha
    2017-05-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • 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 detected the possible presence of glass particles from the cylinder due to damage in its opening, due to the introduction of incorrectly capped bottles into the packing station, which could potentially lead to the presentation of adverse events on patients or reoperations.

Device

HEALON Sterile Viscoelastic Solution
  • Modelo / Serial
  • Descripción del producto
    HEALON GV: indicated to maintain a deep anterior chamber during surgery, allowing efficient handling with greater protection of the corneal endothelium and other surrounding tissues. Use: due to its viscoelasticity it is used to maneuver and control weaves. HEALON: indicated to create and maintain a deep anterior chamber, allowing safe and controlled manipulation in the eye, reducing the risk of trauma to the corneal endothelium and other tissues. Use: it is used to handle, control and separate the tissues in an atraumatic way. HEALON 5: Indicated to create and maintain a deeper anterior chamber than the HEALON, it also creates and maintains a clear visual field during surgical intervention and allows a safe and controlled manipulation in the eye. Use: it is used to manage, control and separate the tissues in an atraumatic way. It can be used to push back an iris prolapse or a bulging vitreous body.
  • Manufacturer
    Amo Uppsala Ab

Manufacturer

Amo Uppsala Ab