Field Safety Notices about OptiLite Multi-Use Holmium Laser Fibers

According to Danish Medicines Agency, this field safety notices involved a device in Denmark that was produced by Cook Incorporated.

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 Number
    2017053356
  • Date
    2017-05-23
  • Event Country
  • Event Source
    DMA
  • Event Source URL
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines 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 Denmark.
  • Extra notes in the data

Device

Manufacturer