BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 6692161 · Received July 7, 2017

    Report

    Report Number
    2648035-2017-01216
    Event Type
    Injury
    Date Received
    July 7, 2017
    Report Date
    August 3, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530584
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA #: P880081. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO ADDITIONAL INVESTIGATION REQUEST FOR THIS PRODUCTION ORDER (PO) NUMBER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A Z9002 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE AS THE PHYSICIAN BELIEVED THAT THE LENS WAS MISLABELED WITH INCORRECT POWER. THE PATIENT MEASURED +6 POST-OP. THE 14.5 DIOPTER LENS WAS REPLACED ANOTHER Z9002 IOL OF A HIGHER DIOPTER (15.0). THE PATIENT WAS REPORTED TO BE DOING BETTER. AS A RESULT OF FOLLOW-UP IT WAS LEARNED THAT THE PHYSICIAN NOW BELIEVES THAT THE IMPLANT WAS CORRECTLY LABELED AS THE PATIENT ENDED UP A +6 AGAIN WITH THE IOL EXCHANGE OF ROUGHLY THE SAME POWER. PER THE PHYSICIAN, THE PATIENT IS GETTING ANOTHER OPINION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475367 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention