Recall Z-1670-2013— Abbott Medical Optics, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Medical Optics, Inc., initiated 2013-05-23, terminated 2014-10-06. It names one FDA 510(k) clearance: K111446. Product: Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.. 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..
- Recalling firm
- Abbott Medical Optics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-23
- Terminated
- 2014-10-06
- Firm location
- Milpitas, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.