Events

Safety Alert for HEALON Sterile Viscoelastic Solution

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Amo Uppsala Ab.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1705-183
  • Event Number
    2010DM-0006480
  • Date
    2017-05-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
  • Product Description
    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