Device Recall Sovereign Compact Phacoemulsification System

"="" designates="" manufacturing="" at="" sanmina-sci="" corporation.="" the="" corporation="" started="" sovereign¿="" compact="" v="" 5.3="" systems="" in="" february="" 2012.="" for="" manufactured="" amo="" usa,="" llc="" facility="" milpitas,="" ca="" serial="" number="" format="" is="" yyyy80xxx="" where="" y="" year="" and="" "80"="" milpitas.="" milpitas="" 2013.="" contained="" product="" identification="" label="" (part="" z352548)="" that="" attached="" to="" rear="" of="" console="" manufactured."="" v-b-tooltip=""> 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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Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.

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