Recall Z-1670-2013 ยท HQC Unit, Phacofragmentation
Abbott Medical Optics, Inc.
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
| Date | Jul 9, 2013 (initiated May 23, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 534 systems |
| Distribution | Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM Abbott Medical Optics, Inc., Dec 21, 2011 |