Z-2970-2011

STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood...

Name: Z-2970-2011 STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood...
Creator: AMO Manufacturing USA, LLC
Published: 2011-07-18
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2011-07-18 / Terminated / root cause: software

FDA source

AMO Manufacturing USA, LLC began a recall of STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is... on 2011-07-18. The reason FDA records is "Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version". 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-2970-2011
Status: Terminated
Initiated: 2011-07-18
Posted: 2011-08-09
Terminated: 2013-09-10
Recalling firm: Advanced Medical Optics, Inc.
Product: STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
Product code: LZS Excimer Laser System
Reason for recall: Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version.
Root cause tag: software
FDA root cause: Software design
Action: Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number. Contact an AMO representative for questions regarding this notice.
Quantity in commerce: 673 total - v5.00 -5.22
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
Product codes and lots: Model # 0030-4793

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)