BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN COMPACT

    MDR report key: 1050152 · Received May 20, 2008

    Report

    Report Number
    2020664-2008-00015
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS (AMO)
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PHACOEMULSIFICATION MACHINE WAS TESTED AND EXAMINED AT THE CUSTOMER LOCATION BY AN AMO SERVICE TECHNICIAN. THE SYSTEM WAS FOUND TO BE OPERATING WITHIN THE SPECIFICATION FOR THE DEVICE.

    Description of Event or Problem · 1

    DURING A ROUTINE CATARACT EXTRACTION PROCEDURE, THE DOCTOR REPORTED EXPERIENCING A CORNEAL BURN IN THE PATIENT'S OPERATIVE EYE. THE INCISION REQUIRED TWO TO THREE SUTURES TO CLOSE. THE PATIENT IS EXPECTED TO HAVE A GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM HQC ADVANCED MEDICAL OPTICS (AMO) CMP680300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PHACOEMULSIFICATION HANDPIECE