Events

Safety Alert for optical biometer - Nidek

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Nidek Co., Ltd..

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
    I1702-59
  • Event Number
    2012DM-0009036
  • Date
    2017-02-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 it has detected unusual variations in the axial length of the screen due to possible external electromagnetic interference in abnormal operating conditions, leading to the occurrence of possible serious adverse events on the patient.

Device

optical biometer - Nidek
  • Model / Serial
  • Product Description
    Medical device that optically measures ocular components such as corneal radius of curvature, corneal thickness, depth of the anterior chamber and axial length.
  • Manufacturer
    Nidek Co., Ltd.

Manufacturer

Nidek Co., Ltd.