Events

Safety Alert for Lensx laser system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Alcon Lensx 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
    I1407-280
  • Event Number
    2012EBC-0008624
  • Date
    2014-07-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • 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 reports that the gantry can descend unexpectedly due to the fact that they have old engine brake systems, which can lead to potentially adverse events occurring on the patient.

Device

Lensx laser system
  • Model / Serial
    LENSX LASER SYSTEM, specific references manufactured before May 2012
  • Product Description
    The LENSX laser is indicated for use in patients who undergo cataract surgery for crystalline removal.
  • Manufacturer
    Alcon Lensx Inc.

Manufacturer

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