Recall Z-1147-06 ยท LZS Excimer Laser System
Alcon Laboratories, Inc.
LADARVision Excimer Laser System.
| Date | Jun 21, 2006 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on CustomCornea procedures, possibly adversely affecting clinical outcomes. |
| Root cause | Other |
| Action | A Medical Device Safety Alert dated August 1, 2005, has been issued to all consignees. Each consignee was issued a Response To Safety Alert form to acknowledge receipt of the Safety Alert. A Field Service Engineer will visit to install the revised software. |
| Quantity | 436 |
| Distribution | There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.