Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
FDA device recall Z-1670-2013 · posted 2013-07-09 · Terminated
Recall details
- Recalling firm
- Abbott Medical Optics, Inc.
- 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.
- Action taken
- AMO issued an "Urgent Notice of Medical Device Correction and Advisory Notice" on May 23, 2013 via email, to all customers with a Sovereign Compact Phacoemulsification System v 5.3 to inform them of the issue and provide them with actions to take in the event of sound loss during use of the Sovereign Compact Phacoemulsification System, v 5.3.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 534 systems
- Distribution
- Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
- Date initiated
- 2013-05-23
- Date posted
- 2013-07-09
- Date terminated
- 2014-10-06
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM (K111446) | Abbott Medical Optics, Inc. | 2011-12-21 |