Events

Safety Alert for Keratometer and non-invasive pupilometer

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

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
    A1603-100
  • Event Number
    2014DM-0010914
  • Date
    2016-03-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=152
  • 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 received two reports related to the inclusion of arched cuts not in the planned surgeries making use of the verion reference unit equipment to be performed with the lensx team, in other countries worldwide. the situation only arises when the equipment in reference is used to plan an intraocular toricas surgery with different marks than those of alcon, leading to the occurrence of adverse events on the patients.

Device

Keratometer and non-invasive pupilometer
  • Model / Serial
    VERION REFERENCE UNIT
  • Product Description
    Keratometer and non-invasive pupilometer, which is additionally used as a planner to determine the surgical plan and determine the appropriate intraocular lens.
  • Manufacturer
    Alcon Gps – Wavelight Gmbh

Manufacturer

Alcon Gps – Wavelight Gmbh
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    NIDFSINVIMA