Events

Safety Alert for intraocular lens in acrylic Tecnis

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Abbott Medical Optics Inc (AMO) || AMO Puerto Rico Manufacturing, Inc || Abbott Manufacturing Malaysia Sdn Bhd.

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
    R1609-385
  • Event Number
    2016DM-0015092
  • Date
    2016-09-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 he has received reports of an unexpected postoperative refraction, after implanting an intraocular lens with incorrect diopter, due to a failure in the manufacturing line due to the intermittent freezing of the screen belonging to the diopter control and resolution device, leading to that potentially adverse events occur on the patients.

Device

intraocular lens in acrylic Tecnis

Manufacturer

Abbott Medical Optics Inc (AMO) || AMO Puerto Rico Manufacturing, Inc || Abbott Manufacturing Mal...