CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
STAR Excimer Laser System with Variable Spot Scanning recalled
Abbott Medical Optics is recalling STAR Excimer Laser System with Variable Spot Scanning, distributed nationwide in the US. The recall was initiated on 16 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0048-2014
- FDA event ID
- 66304
- Recalling firm
- Abbott Medical Optics, Milpitas, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2013
- FDA classified
- 22 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 16 Sep 2013 | Recall initiated by company | |
| 22 Oct 2013 | Classified by FDA | +36 days |
| 30 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
Questions about this recall
Is STAR Excimer Laser System with Variable Spot Scanning recalled?
Yes. Abbott Medical Optics recalled STAR Excimer Laser System with Variable Spot Scanning on 16 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0048-2014.
Why was it recalled?
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).
Which lots are affected?
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.
Where was it sold?
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Medical Optics
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| Device | CLASS II | OptiMedica Catalys Precision Laser System recalled | Abbott Medical Optics | Other | Nationwide |
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