Sovereign¿ Compact Phacoemulsification System — Class II medical device recall Z-1670-2013
Terminated recall by Abbott Medical Optics, Inc., reported 2013-07-17, distributed nationwide. Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice
| Recall number | Z-1670-2013 |
|---|---|
| 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 | 2013-05-23 |
| Classified | 2013-07-09 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 534 systems |
| Model numbers | CMP680300, Z352548 |
Product
Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Reason for recall
Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign¿ Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
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-1670-2013. 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.