Events

Safety Alert for ophthalmic surgery system Constellation Vision System

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
    I1509-421
  • Event Number
    2009EBC-0003112
  • Date
    2015-09-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=172
  • 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 identified that some specific lots with valves have the possibility of leakage, the product is sold as a single element or as part of the constellation equipment kit, leading to potential adverse events on the patient.

Device

ophthalmic surgery system Constellation Vision System
  • Model / Serial
    23G & 25+ and CUSTOM PACKS, specific lots
  • Product Description
    This equipment is a multifunctional surgical tool for use in ophthalmic surgeries in the anterior and posterior segments. The possibilities of the product include the use of paracortar the vitreous and tissue, emulsify the lens, illuminate the posterior segment of the eye and apply diathermy to stop the hemorrhage. The vacuum is used to remove ocular matter from the eye, the irrigation / infusion option serves to replenish the eye fluid.
  • Manufacturer
    Alcon Laboratories Inc

Manufacturer

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