Events

Safety Alert for Diode Laser System LIGHTSHEER LUMENIS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Lumenis 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
    A1607-312
  • Event Number
    2010EBC-0005904 ; 2010EBC-0005551
  • Date
    2016-07-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=129
  • 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 it has detected that the software was installed a software where the pre-established treatments do not coincide with the operator manual, resulting in more aggressive techniques than those recommended, which can lead to potential serious adverse events occurring on the patient.

Device

Diode Laser System LIGHTSHEER LUMENIS
  • Model / Serial
    LIGHTSHEER DESIRE, serial all systems with XC handpiece.
  • Product Description
    Destined for temporary hair removal, or long-term or permanent hair reduction, by selective application to melanin of the hair follicles. Used for pseudofolliculitis, treatment of varicose veins, benign vascular lesions, angiomas, hemangiomas and telangiectasia
  • Manufacturer
    Lumenis Inc

Manufacturer

Lumenis Inc