Events

Recall of IFS ADVANCED FEMTOSECOND LASER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMO CANADA COMPANY.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    17570
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Abbott medical optics inc. initiated this event after becoming aware of a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 micrometres or deeper) created using the femtosecond laser system. this discrepancy between the user-set depth of corneal tissue incision and the actual depth of those incisions was discovered during an engineering investigation conducted prior to the launch outside the united states of a new indication for arcuate incision procedures. the engineering investigation was not initiated due to the receipt of a complaint.

Device

IFS ADVANCED FEMTOSECOND LASER
  • Model / Serial
    Model Catalog: MODEL IFS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FS (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: MODEL 2 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    IFS ADVANCED FEMTOSECOND LASER
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY