Events

Safety Alert for ALCON Surgical Microscope

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

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
    I1706-244
  • Event Number
    2013DM-0009932
  • Date
    2017-05-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=86
  • 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 informs that it has identified the possibility of a crash against some wheel of the device could exert pressure on its base, causing its rupture or its separation from the base, this situation added to the position of the arm could result in a rollover, leading to the occurrence possible adverse events on users or patients.

Device

ALCON Surgical Microscope
  • Model / Serial
  • Product Description
    Microscopes to provide visual amplification, during ophthalmic surgical interventions, including decatarata surgery, retina, cornea, etc.
  • Manufacturer
    Alcon Laboratories Inc.

Manufacturer

Alcon Laboratories Inc.
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    NIDFSINVIMA