Events

Recall of Device Recall Sovereign Compact Phacoemulsification System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Medical Optics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65292
  • Event Risk Class
    Class 2
  • Event Number
    Z-1670-2013
  • Event Initiated Date
    2013-05-23
  • Event Date Posted
    2013-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118560
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, phacofragmentation - Product Code HQC
  • Reason
    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
    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.

Device

Device Recall Sovereign Compact Phacoemulsification System
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
  • Product Description
    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
  • Manufacturer
    Abbott Medical Optics, Inc.

Manufacturer

Abbott Medical Optics, Inc.
  • Manufacturer Address
    Abbott Medical Optics, Inc., 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA