FDA Device Recall Z-1670-2013: Abbott Medical Optics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1670-2013.

Recall Res Number

Z-1670-2013

Recalling Firm / Manufacturer

Abbott Medical Optics, Inc.

FEI Number

3006695864

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-05-23

Date Posted

2013-07-09

Date Terminated

2014-10-06

Product Code

HQC

Event Number

65292

Product Quantity

534 systems

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.

Action Details 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.

Distribution Pattern Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.

Code Information / Serial Numbers 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.

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Medical Device Recall: Z-1670-2013

Recall Parameters & Description

Related Establishments / Registrations

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