Events

Field Safety Notices about Artisan and Artiflex

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Ophtec BV..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    6.6.4-2014-104897
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Implantat--Artisan-och-Artiflex--Ophtec-BV/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Extra notes in the data
    QB140101.TO
  • Action
    Modification of the manual. Follow-up patient. The manufacturer has changed the recommendation on patient follow-up. In order to assess the lens security over time, patients should be examined every 6 months after surgery. The follow-up study should include verification of the number of endothelial cells, and the follow-up of visits should be increased to once every 6 months in the case where the reduction in cell number exceeds the physiological normal value or when the measurements of anterior chamber shows that the anterior chamber is becoming more because due to cataract development.

Device

Artisan and Artiflex
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant
  • Manufacturer
    Ophtec BV.

Manufacturer

Ophtec BV.