BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2240423 · Received September 9, 2011

    Report

    Report Number
    9614546-2011-00079
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED CUT IN PIECES PRECLUDING DIOPTER MEASUREMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED IT MET ALL SPECIFICATIONS. A VISUAL INSPECTION OF THE OPTIC PARTS TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. THE DIOPTER MEASUREMENT RECORDS FROM THIS PARTICULAR LENS WAS REVIEWED AND SHOWED TO BE WITHIN SPECIFICATIONS. THIS IS IN COMPLIANCE WITH THE LABELED DIOPTRIC POWER 14.5 DIOPTER OF THIS LOT NUMBER. NO SIMILAR COMPLAINTS WERE RECEIVED FOR THE REMAINING LENSES IN THIS PRODUCTION ORDER. THE MANUFACTURER'S IMPLANT DATABASE WAS REVIEWED AND CONFIRMED THE ORIGINAL MULTIFOCAL LENS IMPLANT WAS REPLACED WITH A MONOFOCAL LENS. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCIES SUGGESTING THIS EVENT WAS NOT CAUSED BY THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED 1 MONTH AFTER IMPLANT. REASON STATED WAS THE PATIENT'S INABILITY TO ADAPT TO NEAR VISION. NO PATIENT INJURY OR COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention