Events

Field Safety Notices about Femtosecond Laser System

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by AMO Manufacturing USA, LLC.

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
    SN2011(34)
  • Date
    2011-12-19
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/femtosecond-laser-system&id=8480f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    A discrepancy may exist between the user-set depth of corneal tissue incisions and the actual depth of those incisions whilst performing procedures with femtosecond laser systems.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of this  issue.  2. If you require further details relating to this discrepancy and its impact on  deep corneal incision procedures, please contact AMO for further guidance  and information regarding this issue.  3. If you have an affected device confirm that the recommended actions have been completed.

Device

Femtosecond Laser System

Manufacturer

AMO Manufacturing USA, LLC