Z-1124-03

Intralase FS Laser System. Laser Keratome

Name: Z-1124-03 Intralase FS Laser System. Laser Keratome
Creator: Intralase Corp
Published: 2003-07-15
License: https://open.fda.gov/license/

Intralase Corp / initiated 2003-07-15 / Terminated

FDA source

Intralase Corp began a recall of Intralase FS Laser System. Laser Keratome on 2003-07-15. The reason FDA records is "Gantry moves toward patient when 'Home' button is used after procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1124-03
Status: Terminated
Initiated: 2003-07-15
Posted: 2003-08-12
Terminated: 2004-12-02
Recalling firm: Intralase Corp
Product: Intralase FS Laser System. Laser Keratome
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Gantry moves toward patient when 'Home' button is used after procedure.
FDA root cause: Other
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.
Quantity in commerce: 70
Distribution: Nationwide and Japan.
Product codes and lots: All codes

Product code GEX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)