Events

Field Safety Notices about IOL Master 500

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Carl Zeiss.

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 Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    With this letter we would like to inform you about a mandatory software update for your iolmaster. this applies only to iolmaster devices with software version 7.5.2, 7.7.2 and 7.7. 3. all other versions are not affected. these versions of software have a software defect which can result in incorrect iol calculations being presented on screen and in a printout/export in rare cases when a specific non-standard workflow is used. .

Device

IOL Master 500

Manufacturer

Carl Zeiss