Z-1670-2013Class II

Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract...

Name: Z-1670-2013 Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract...
Creator: Abbott Medical Optics, Inc.
Published: 2013-05-23
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2013-05-23 / Terminated / root cause: software

FDA source

Abbott Medical Optics, Inc. began a recall of Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery on 2013-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1670-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-23
Posted: 2013-07-09
Terminated: 2014-10-06
Recalling firm: Advanced Medical Optics, Inc.
Product: Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Product code: HQC Unit, Phacofragmentation
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.
Root cause tag: software
FDA 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 in commerce: 534 systems
Distribution: Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1670-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1670-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-09

Product code HQC

K111446Class IISovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. / cleared 2011-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)