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U.S. Department of Health and Human Services

Class 2 Device Recall Sovereign Compact Phacoemulsification System

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 Class 2 Device Recall Sovereign Compact Phacoemulsification Systemsee related information
Date Initiated by FirmMay 23, 2013
Date PostedJuly 09, 2013
Recall Status1 Terminated 3 on October 06, 2014
Recall NumberZ-1670-2013
Recall Event ID 65292
510(K)NumberK111446 
Product Classification Unit, phacofragmentation - Product Code HQC
ProductSovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Code Information Product Name: Sovereign¿ Compact Console Universal, Part Number: CMP680300. The Sovereign¿ Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign¿ Compact systems manufactured at the Third Party Manufacturer, Sanmina-SCI Corporation, the serial number format is YYYY35XXX where Y is for the year manufactured and "35" designates manufacturing at Sanmina-SCI Corporation. The Sanmina-SCI Corporation started manufacturing the Sovereign¿ Compact v 5.3 systems in February 2012. For Sovereign¿ Compact systems manufactured at the AMO Manufacturing USA, LLC facility in Milpitas, CA the serial number format is YYYY80XXX where Y is for the year manufactured and "80" designates manufacturing at Milpitas. The Milpitas facility started manufacturing the v 5.3 systems in February 2013. The serial number is contained in the Product Identification Label (part number Z352548) that is attached to the rear of the console for systems manufactured.
FEI Number 3006695864
Recalling Firm/
Manufacturer		 Abbott Medical Optics, Inc.
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information Contact
408-273-4100
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionAMO 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 in Commerce534 systems
DistributionWorldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HQC
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