Events

Safety Alert for Ophthalmic Surgical Laser

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ellex Medical Pty Lyd.

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
    I1608-316
  • Date
    2016-08-01
  • 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 warns that it has detected the possibility that using the referenced filters the user could be exposed to a diffuse reflection of the laser beam, leading to the presentation of possible adverse events on the users.

Device

Ophthalmic Surgical Laser
  • Model / Serial
    Concerning the eye safety filters of the INTEGRE LP5532 and 2RT models, manufactured between July || 2012 and February 2016, specific serials.
  • Product Description
    Depending on the frequency of the equipment, there are several applications among which are iridotomies, capsulotomies, selective laser trabeculoplasty, photocoagulation.
  • Manufacturer
    Ellex Medical Pty Lyd

Manufacturer

Ellex Medical Pty Lyd