Events

Safety Alert for ORA system with Verifeye

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Alcon Research Ltd || 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
    I1708-392
  • Event Number
    2016DM-0014375
  • Date
    2017-08-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • 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

Device

ORA system with Verifeye
  • Model / Serial
    Models with VerifEye and VerifEye + Cart, specific serials.
  • Product Description
    The ORA SYSTEM is intended for use in the measurement and analysis of the refractive power of the eye ie measurement of the sphere, cylinder and shaft.
  • Manufacturer
    Alcon Research Ltd || Alcon Laboratories Inc

Manufacturer

Alcon Research Ltd || Alcon Laboratories Inc
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    NIDFSINVIMA