Events

Safety Alert for perfluorocarbon liquid for ophthalmic use - Arcotane

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

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
    R1512-590
  • Event Number
    2015DM-0013671
  • Date
    2015-12-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • 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 that there were severe vision loss events after the surgery without retinal detachment, in a preventive way the withdrawal of the lots involved has been initiated.

Device

perfluorocarbon liquid for ophthalmic use - Arcotane
  • Model / Serial
    ARCOTANE 5ml and 7ml, lots 9432774, 9433347, 9433706 and 9433348
  • Product Description
    Medical device to be used for the pre-operative tamponade of retinal detachment to re-apply the retinal.
  • Manufacturer
    Arcadophta Sarl

Manufacturer

Arcadophta Sarl
  • Manufacturer Parent Company (2017)
    Arcadophta
  • Source
    NIDFSINVIMA