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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65292
Product Type Devices
Status Ongoing
Recalling Firm Abbott Medical Optics, Inc.
City Milpitas
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sovereign® Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. 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. Class II 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. 534 systems Z-1670-2013
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