BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1832471 · Received September 13, 2010

    Report

    Report Number
    2648035-2010-00173
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RECEIVED BY THE MANUFACTURER FOR ANALYSIS. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. HALOS AND/OR GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL INTRAOCULAR LENSES. WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND THE RESULTS OF THE VISUAL AND OPTICAL INSPECTIONS PERFORMED WERE FOUND WITHIN PRODUCT SPECIFICATIONS. THE DIOPTER MEASURED CORRECT AS LABELED, 22.0 D. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL IOL IMPLANTS. THE REPORTER STATED THE MULTIFOCAL LENS WAS REPLACED WITH A MONOFOCAL LENS OF THE SAME DIOPTER. WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(4) EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE AND HAD THE CAREGIVER CYCLE POWER TO CLEAR THE ALARM. (B)(4) ADVISED THE CAREGIVER TO START OVER USING NEW SUPPLIES. THERAPY HAD BEEN STARTED PRIOR TO THE PATIENT CONNECTING. UPON CONNECTION, THE HC ALARMED WITH THE SYSTEM ERROR 2240. PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT'S DIALYSIS NURSE. THE NURSE STATED THE SHE WAS NOT AWARE OF THE EVENT BUT AS FAR AS SHE KNEW, THE PATIENT HAD CONTINUED THERAPY WITHOUT COMPLICATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A MONOFOCAL IOL 4 MONTHS AFTER INITIAL IMPLANT. THE REASON STATED WAS THE PATIENT'S UNHAPPINESS WITH HER VISION. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention