Recall Z-1670-2013
Abbott Medical Optics, Inc. · initiated May 23, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Codes / 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.
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: Software design
Action taken
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.
Details
- Recall number
- Z-1670-2013
- Initiated
- May 23, 2013
- Posted by FDA
- July 9, 2013
- Terminated
- October 6, 2014
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 534 systems
- Distribution
- Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
- Recalling firm
- Abbott Medical Optics, Inc., Milpitas, CA