BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN CATARACT EXTRACTION SYSTEM

    MDR report key: 3130716 · Received May 24, 2013

    Report

    Report Number
    2020664-2013-00029
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4) - DELAY IN COMPLETION OF SURGERY. MANUFACTURING YEAR - 2006. ACCOUNT REPORTED THERE WAS NO PATIENT INJURY HOWEVER, THERE WAS A SIGNIFICANT DELAY IN COMPLETING THE PROCEDURE. A FIELD SERVICE ENGINEER (FSE) ATTENDED THE OPERATION THE NEXT DAY ((B)(6) 2013). THE FSE CHECKED THE SOVEREIGN CONSOLE IN QUESTION AT THE CUSTOMER SITE, BUT THE MACHINE WAS WORKING AS EXPECTED. NO PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRIMING WAS COMPLETED SUCCESSFULLY PRIOR TO THE SURGERY. FOLLOWING TO CCC (CONTINUOUS CURVILINEAR CAPSULORRHEXIS), IT FAILED TO VACUUM THE SURFACE EPITHELIUM AT ALL, AND ERROR 503 (LOW VACUUM ERROR) OCCURRED. THE CUSTOMER REBOOTED THE SYSTEM AND REPLACED THE TUBING PACK; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE CUSTOMER FOUND THAT THE PUMP WAS ROTATING BACKWARD. DESPITE REPLACING A FEW TUBING PACKS AND USING SIX BOTTLES OF BSS (BALANCED SALT SOLUTION), THE ISSUE WAS NOT RESOLVED. THE SURGERY WAS DISCONTINUED ON THE DAY. THE NEXT DAY, ((B)(6) 2013), THE SURGERY WAS PERFORMED WITH A SUBSTITUTE SIGNATURE CONSOLE AND SUCCESSFULLY COMPLETED. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230933 SOVEREIGN CATARACT EXTRACTION SYSTEM SOVEREIGN HQC ABBOTT MEDICAL OPTICS SOV680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other