Events

Safety Alert for OPTIMEDICA CATALYS PRECISION LASER SYSTEM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Optimedical Corporation || Abbott Medical Optics 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
    I1505-201
  • Event Number
    2014EBC-0011800
  • Date
    2015-05-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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 states that medical-referenced devices may present a loss of suction during treatment, in addition to the alteration in the incision mode of cataract, resulting in the same parameters for both eyes, leading to potentially adverse events occurring in patients.

Device

OPTIMEDICA CATALYS PRECISION LASER SYSTEM
  • Model / Serial
    OPTIMEDICA CATALYS, lot 44067514, Software Version 3.00.05
  • Product Description
    The equipment OPTIMEDICA CATALYS PRECISION LASER SYSTEM (system laser of precision), with interface of opticaliquida is used to create a capsulotomia anterior of precision and / or the subsequent facofragmentación of the lens, with or without cuts in arc in one or multiple planes of the cornea. The CATALYS precision laser system is indicated for the removal of the lens in patients who are going to undergo cataract surgery.
  • Manufacturer
    Optimedical Corporation || Abbott Medical Optics Inc.

Manufacturer

Optimedical Corporation || Abbott Medical Optics Inc.
  • Source
    NIDFSINVIMA