BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 6239940 · Received January 11, 2017

    Report

    Report Number
    2648035-2017-00066
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Report Date
    April 26, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS AND COMPLAINT HISTORY REVIEW COULD NOT BE COMPLETED AS THE SERIAL NUMBER WAS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF AN EXPLANT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN AT LEAST FIVE CASES THE HAPTICS WERE GETTING STUCK ONTO THE OPTIC. IT WAS STATED THAT THEY ALMOST ALWAYS SPONTANEOUSLY RELEASED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23030 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1