Events

Alerte De Sécurité sur HEALON Sterile Viscoelastic Solution

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Amo Uppsala Ab.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1705-183
  • Numéro de l'événement
    2010DM-0006480
  • Date
    2017-05-19
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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