Z-0048-2014Class II

STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is...

Name: Z-0048-2014 STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is...
Creator: Abbott Medical Optics, Inc.
Published: 2013-09-16
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2013-09-16 / Terminated / root cause: manufacturing process

FDA source

Abbott Medical Optics, Inc. began a recall of STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing... on 2013-09-16. FDA classified it as Class II and gives the reason as "This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0048-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-10-22
Terminated: 2014-11-12
Recalling firm: Advanced Medical Optics, Inc.
Product: STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Product code: LZS Excimer Laser System
Reason for recall: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Abbott Medical Optics, Inc., (AMO), sent an "ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff. If you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.
Quantity in commerce: 834 units in total
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
Product codes and lots: All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0048-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22
Z-0047-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22
Z-0048-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22
Z-0049-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22

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)