Events

Recall of Intralase FS Laser System. || Laser Keratome

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intralase Corp.

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
    26826
  • Event Risk Class
    Class 2
  • Event Number
    Z-1124-03
  • Event Initiated Date
    2003-07-15
  • Event Date Posted
    2003-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28521
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered Laser Surgical Instrument - Product Code GEX
  • Reason
    Gantry moves toward patient when 'home' button is used after procedure.
  • Action
    Firm sent Safety Alert letters to customers on July 15, 2003 by registered mail instructing not to use the HOME button, including a 'Do Not Use' sticker for the machine and an addendum to the Operations Manual.

Device

Intralase FS Laser System. || Laser Keratome

Manufacturer

Intralase Corp
  • Manufacturer Address
    Intralase Corp, 3 Morgan, Irvine CA 926181916
  • Source
    USFDA