Z-1695-2008

Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and...

Name: Z-1695-2008 Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and...
Creator: Visx Incorporated, a Subsidiary of Amo Inc
Published: 2006-11-17
License: https://open.fda.gov/license/

Visx Incorporated, a Subsidiary of AMO Inc / initiated 2006-11-17 / Terminated / root cause: software

FDA source

VISX INCORPORATED, A SUBSIDIARY OF AMO INC began a recall of Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a... on 2006-11-17. The reason FDA records is "Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determined to be...". 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-1695-2008
Status: Terminated
Initiated: 2006-11-17
Posted: 2008-08-20
Terminated: 2010-06-08
Recalling firm: Visx Incorporated, a Subsidiary of AMO Inc
Product: Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
Product code: LZS Excimer Laser System
Reason for recall: Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determined to be extremely remote. To ensure that this type of incident will not happen again, a software update was developed.
Root cause tag: software
FDA root cause: Software design
Action: VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.
Quantity in commerce: 1310 units
Distribution: Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
Product codes and lots: All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.

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)