BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11290203 · Received February 6, 2021

    Report

    Report Number
    9614546-2021-07052
    Event Type
    Injury
    Date Received
    February 6, 2021
    Date of Event
    November 24, 2020
    Report Date
    February 5, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474660052
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. TELEPHONE NUMBER: (B)(6). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT ALL SCRUB TECHS WERE OUT AND THE INTRAOCULAR LENS (IOL) MAY HAVE BEEN IMPROPERLY LOADED AS THE LEADING HAPTIC DID NOT FOLD PROPERLY. THE LENS WAS LOADED WITH THE FRONT HAPTIC SLIGHTLY STRAIGHT. AS THE LENS WAS INJECTED INTO THE PATIENT¿S RIGHT EYE, THE FRONT HAPTIC CAUGHT THE POSTERIOR CAPSULE AND CREATED A TEAR. THERE WAS PATIENT ZONULES ISSUE AND HAPTICS WOULD NOT SIT PROPERLY. THE LENS WAS IMPLANTED, THEN WAS CUT AND REMOVED FROM THE EYE DURING THE SAME PROCEDURE. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED, THE SITE WAS SLIGHTLY ENLARGED TO ACCOMMODATE THE LENS AND SUTURES WERE USED TO CLOSE IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON AND JOHNSON 3-PIECE LENS. THE PATIENT WAS REPORTED TO BE FINE AND NO ISSUES WERE REPORTED UPON DISCHARGE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186875 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS ZCU300 05050474660052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention