Events

Safety Alert for Surgical System of Facofragmentation - CENTURION

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
    R1605-209
  • Event Number
    2013EBC-0010838
  • Date
    2016-05-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 due to the possible presence of irregularities in the shape of the suction cups, which can result in a reduction of the vacuum inside the suction line, which does not allow to reach the maximum programmed vacuum, leading to adverse events on patients. and delays in the procedures.

Device

Surgical System of Facofragmentation - CENTURION
  • Model / Serial
    Concerning your Packs for CENTURION FMS (fluid management system), reference 8065752182, lots || 1794545H and 1794549H
  • Product Description
    Designed for use by physicians in phacoemulsification, separation and elimination of cataracts, removal of residual cortical material and epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation and intraocular lens injection.
  • Manufacturer
    Alcon Laboratories Inc.

Manufacturer

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