BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1871943 · Received October 16, 2010

    Report

    Report Number
    2648035-2010-00195
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 21, 2006
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P960028/SO11
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) ASSOCIATED WITH THIS REPORT WAS RECEIVED AND TRANSFERRED TO THE MANUFACTURING FACILITY FOR ANALYSIS, RESULTS ARE PENDING. A FOLLOW-UP TO THIS MDR WILL BE SUBMITTED WHEN THE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS (IOL) WAS INSPECTED AND MET ALL MANUFACTURING SPECIFICATIONS. THE IOL POWER WAS MEASURED AND IS CORRECT AS LABELED, 19.0 DIOPTERS. THE LENS WAS INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION AND THE OPTIC SHOWED NO DEFECTS. THE RESULTS OF THE VISUAL AND OPTICAL INSPECTIONS PERFORMED WERE FOUND WITHIN ALL PRODUCT SPECIFICATIONS. BATCH RECORDS WERE REVIEWED AND NO DEVIATIONS WERE NOTED. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT SUDDENLY MOVED AND THEN COUGHED. AS A RESULT, FLUID WAS OBSERVED AT THE UTERUS AND THE SMALL PARTS OF THE BUTTOCK'S WERE BLISTERED. CLINICAL FOLLOW UP INFORMATION REVEALED THAT A TENACULUM WAS USED TO MAINTAIN A CERVICAL SEAL AND A TENACULUM STABILIZER WAS ALSO USED, THE BURN WAS CATEGORIZED AS "2ND DEGREE", A FLUID LOSS ALARM WAS GENERATED AT 10 CC'S, BURNS WERE BOTH INTERNAL AND EXTERNAL AND BURNS WERE TREATED WITH LIDOCAINE AND SILVADENE CREAM. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OK". AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS REMOVED AND REPLACED WITHOUT COMPLICATION 4 YEARS AFTER THE INITIAL IMPLANT. REASON STATED WAS EXPLANTED DUE TO IMPROPER IOL POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REZOOM MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS NXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention