BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 7123914 · Received December 15, 2017

    Report

    Report Number
    9614546-2017-01234
    Event Type
    Injury
    Date Received
    December 15, 2017
    Report Date
    May 11, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE VERIFIED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE LENS WAS NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION WAS NOT PROVIDED. BUT WAS STATED AS APPROXIMATELY (B)(6) 2017. THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT THAT LOOKED PERFECT AT THE FIRST POST-OPERATIVE VISIT, WAS LATER FOUND, ON A FOLLOW UP VISIT, THAT THE IOL WAS SUBLIME WITH THE HAPTIC IN MID PUPIL. REPORTEDLY, THE SURGERY HAD BEEN PERFECT, ALTHOUGH THE IOL HAD A HAPTIC STICK AGAINST THE OBTURATOR OF THE PLATINUM INSERTER. ALSO, THE TRAILING HAPTIC CAUGHT AGAINST THE CARTRIDGE AND DID NOT FOLD OVER THE OPTIC. FURTHERMORE, WHEN DISENGAGED, THE IOL WAS INVERTED AND WITH EXTRA VISCOELASTIC IT WAS FLIPPED OVER. REPORTEDLY, THE DOCTOR BELIEVES THE PATIENT MAY HAVE POSSIBLE INFERIOR ZONULAR DIALYSIS AND BELIEVES IT WOULD BE BEST TO EXCHANGE THE LENS TO A MODEL ZMA00 15.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899670 TECNIS MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention