Z-1147-06

LADARVision Excimer Laser System

Name: Z-1147-06 LADARVision Excimer Laser System
Creator: Alcon Laboratories, Inc.
Published: 2005-08-01
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2005-08-01 / Terminated / root cause: software

FDA source

Alcon Laboratories, Inc. began a recall of LADARVision Excimer Laser System on 2005-08-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1147-06
Status: Terminated
Initiated: 2005-08-01
Posted: 2006-06-21
Terminated: 2012-07-06
Recalling firm: Alcon Laboratories
Product: LADARVision Excimer Laser System.
Product code: LZS Excimer Laser System
Reason for recall: 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 tag: software
FDA 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 in commerce: 436
Distribution: There have been 285 units distributed in the US and 151 units distributed to International Alcon Affiliates.
Product codes and lots: CustomCornea software only. System serial numbers with prefix L4N and L4U.

Product code LZS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)