Safety Alert for SH-System Monatslinsen contact lenses

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by 4Care AG.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: 4care ag’s sh-system monatslinsen contact lenses the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice on 4care ag’s monthly contact lenses “sh-system monatslinsen” due to the presence of small parts of silicone oil in some lots of the products. it may lead to blurry view or a foreign body sensation in the eye. sometimes it can lead to eye pain. 4 care ag is conducting a recall of the product.For details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: 4Care AG's SH-System Monatslinsen contact lenses
  • Manufacturer


  • Source