BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2060351 · Received April 15, 2011

    Report

    Report Number
    9614546-2011-00024
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED BUT HAS NOT YET BEEN EVALUATED. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE SURGEON IMPLANTED A LOWER DIOPTER LENS OF THE SAME MODEL SUGGESTING THIS EVENT WAS NOT CAUSED BY THE IOL. ALL INFORMATION CURRENTLY AVAILABLE IS CONTAINED IN THIS REPORT. A SUPPLEMENTAL REPORT WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MULTIFOCAL INTRAOCULAR LENS WAS RECEIVED CUT IN HALF ACROSS THE OPTIC. VISUAL INSPECTION OF THE OPTIC PARTS TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO OTHER COMPLAINTS FROM THIS ORDER NUMBER WERE RECEIVED. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED WITHOUT COMPLICATION 1 WEEK POSTOPERATIVE. THE REASON STATED WAS LENS POWER OFF BY 3 POWERS. THE LENS WAS REPLACED WITH A LOWER DIOPTER LENS OF THE SAME MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention