Z-0854-2007

LADAR6000 Excimer Laser System

Name: Z-0854-2007 LADAR6000 Excimer Laser System
Creator: Alcon Refractive Horizons, Inc.
Published: 2007-02-21
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2007-02-21 / Terminated / root cause: software

FDA source

Alcon Refractive Horizons, Inc. began a recall of LADAR6000 Excimer Laser System on 2007-02-21. The reason FDA records is "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...". 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-0854-2007
Status: Terminated
Initiated: 2007-02-21
Posted: 2007-06-05
Terminated: 2017-03-21
Recalling firm: Alcon Laboratories
Product: LADAR6000 Excimer Laser System
Product code: LZS Excimer Laser System
Reason for recall: 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 tag: software
FDA 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. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.
Quantity in commerce: 102
Distribution: Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
Product codes and lots: All serial/lot numbers of the LADAR6000

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)