Z-1374-2011

AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog...

Name: Z-1374-2011 AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog...
Creator: AMO Manufacturing USA, LLC
Published: 2010-07-13
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2010-07-13 / Terminated / root cause: software

FDA source

AMO Manufacturing USA, LLC began a recall of AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67... on 2010-07-13. The reason FDA records is "The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result". 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-1374-2011
Status: Terminated
Initiated: 2010-07-13
Posted: 2011-02-18
Terminated: 2012-06-22
Recalling firm: Advanced Medical Optics, Inc.
Product: AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.
Product code: LZS Excimer Laser System
Reason for recall: The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result.
Root cause tag: software
FDA root cause: Software design
Action: Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to take the following actions: Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530. For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to [email protected]. For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.
Product codes and lots: All units of these Catalog Numbers. Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 nternational version

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)