Safety Alert for Intraocular Lenses - SOFTPORT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Bausch & Lomb Incorporated.

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
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 detected the increased risk of derupture of the intraocular lens grip, leading to the generation of possible adverse events on the patient.


  • Model / Serial
    SOFTPORT AO model LI61AO
  • Product Description
    Intraocular silicone lens to be implanted in the capsular lens bag or ciliary sulcus by surgery, to replace the natural human lens and perform a visual correction of aphakia.
  • Manufacturer