FDA Medical Device Recalls (openFDA)
Alcon Laboratories, Inc.: LADARVision Excimer Laser System.
- Recall number
- Z-1147-06
- Recalling firm
- Alcon Laboratories, Inc.
- Product
- LADARVision Excimer Laser System.
- Status
- Terminated
- Initiated
- 2005-08-01
- Posted
- 2006-06-21
- Terminated
- 2012-07-06
- 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.
- Lot, serial or model codes
- CustomCornea software only. System serial numbers with prefix L4N and L4U.
- 510(k) numbers
- not on file
- PMA numbers
- ["P970043"]
- Product code
- LZS
- Firm FEI
- 3000209733
- Firm city
- Orlando
- Firm state
- FL
- 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