STAR Excimer Laser System with Variable Spot Scanning — Class II medical device recall Z-0048-2014
Terminated recall by Abbott Medical Optics, Inc., reported 2013-10-30, distributed nationwide. This corrective action will address an identified failure of the lamp and illumination system within the laser
| Recall number | Z-0048-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical Optics, Inc., Milpitas, CA, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-10-22 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 834 units |
| Model numbers | 0030-4077 |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0048-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.