Intralase FS Laser System. Laser Keratome
FDA device recall Z-1124-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Intralase Corp
- Reason for recall
- Gantry moves toward patient when 'Home' button is used after procedure.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 70
- Distribution
- Nationwide and Japan.
- Date initiated
- 2003-07-15
- Date posted
- 2003-08-12
- Date terminated
- 2004-12-02
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULSION FS LASER KERATOME (K013941) | Intra Lase Corp. | 2002-02-27 |
| INTRALASE 600C LASER KERATOME (K002890) | Intra Lase Corp. | 2001-08-09 |
| MODIFICATION TO INTRALASE 600C LASER KERATOME (K001211) | Intra Lase Corp. | 2000-12-04 |
| INTRALASE 600C LASER KERATOME (K993153) | Intra Lase Corp. | 1999-12-17 |