Recall Z-0854-2007 ยท LZS Excimer Laser System
Alcon Refractive Horizons, Inc.
LADAR6000 Excimer Laser System
| Date | Jun 5, 2007 (initiated Feb 21, 2007) |
| Status | Terminated |
| Reason | Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated) |
| Root cause | Other |
| Action | Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Not |
| Quantity | 102 |
| Distribution | Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.