Z-1540-2013Class II

STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood...

Name: Z-1540-2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood...
Creator: Abbott Medical Optics, Inc.
Published: 2013-05-28
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2013-05-28 / Terminated

FDA source

Abbott Medical Optics, Inc. began a recall of STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser... on 2013-05-28. FDA classified it as Class II and gives the reason as "Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1540-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-06-13
Terminated: 2014-11-12
Recalling firm: Advanced Medical Optics, Inc.
Product: STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Product code: LZS Excimer Laser System
Reason for recall: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
FDA root cause: Other
Action: AMO Manufacturing sent an Advisory Notice dated May 28, 2013, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the attached advisory notice to all affected customers in their assigned region. Customers were instructed to notify each surgeion at their site and complete and return the attached form to AMO via fax as an an acknowledgement of receipt of this advisory notice and that they understand the information contained within the letter. Customers with questions were instructed to contact their regional contact. For questions regarding this recall call 408-273-4016.
Quantity in commerce: 1,882 - total all systems
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .
Product codes and lots: Model 0030-4077 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1540-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1539-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12
Z-1540-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12
Z-1541-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12

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)