FDA Medical Device Recalls (openFDA)
Intralase Corp: Intralase FS Laser System. Laser Keratome
- Recall number
- Z-1124-03
- Recalling firm
- Intralase Corp
- Product
- Intralase FS Laser System. Laser Keratome
- Status
- Terminated
- Initiated
- 2003-07-15
- Posted
- 2003-08-12
- Terminated
- 2004-12-02
- Reason
- Gantry moves toward patient when 'Home' button is used after procedure.
- 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
- 70
- Distribution
- Nationwide and Japan.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K013941","K993153","K001211","K002890"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3002930984
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28