STAR S4 with Variable Spot Scanning Excimer System — Class II medical device recall Z-1540-2013
Terminated recall by Abbott Medical Optics, Inc., reported 2013-06-19, distributed nationwide. Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
| Recall number | Z-1540-2013 |
|---|---|
| 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 | 2013-05-28 |
| Classified | 2013-06-12 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BG, BO, BR, CA, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GR, GT, HK, HR, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, MX, MY, NL, NO, NZ, OM, PE, PL, PT, RO, SA, SE, SG, SK, SV, TH, TR, TT, TW, UA, VE, VN |
| Quantity | 1,882 |
| Model numbers | 0030-4077 |
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.
Reason for recall
Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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-1540-2013. 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.