Recall Z-1124-03 ยท GEX Powered Laser Surgical Instrument
Intralase Corp
Intralase FS Laser System. Laser Keratome
| Date | Aug 12, 2003 (initiated Jul 15, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |