Events

Safety Alert for Ophthalmic Viscosurgical Device Healon EndoCoat and Healon Duet Dual

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Amo Ireland. || 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
    I1411-479
  • Event Number
    2013DM-0010182
  • Date
    2014-11-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 it has received reports of incidents in which the grip with the fingers of the devices dislodged while the user presses the plunger of the syringe, if the grip groove is dislodged, the hand of the surgeon could accidentally move the cannula, resulting in a trauma in the patient's eye, this situation can be dislodged if the user does not follow the instructions for use (dfu), leading to potential adverse events occurring on the patient.

Device

Ophthalmic Viscosurgical Device Healon EndoCoat and Healon Duet Dual
  • Model / Serial
  • Product Description
    The HEALON ENDOCOAT ophthalmic visco-surgical device is used in anterior-calculus-soft surgical procedures, including: decatarata surgery with an intraocular lens, cataract surgery without an intraocular lens, implantation of intraocular-secondary lens.
  • Manufacturer
    Amo Ireland. || Abbott Medical Optics Inc.

Manufacturer

Amo Ireland. || Abbott Medical Optics Inc.