BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19169811 · Received April 23, 2024

    Report

    Report Number
    3012236936-2024-01198
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 23, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474560758
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS PARTIALLY IMPLANTED DUE TO PATIENT HAVING INCREASED OCULAR PRESSURE (IOP). ANOTHER ZLB00 24.0 DIOPTER IOL WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT WAS GIVEN ALPHAGAN DROP AND DIAMOX SEQUELS TO REDUCE IOP THAT PERSISTED UNTIL THE NEXT DAY. PATIENT DID NOT EXPERIENCE ANY VISUAL ISSUES DUE TO IOP. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, AND NO SURGICAL COMPLICATIONS. PATIENT PROGNOSIS POST-PROCEDURE WAS REPORTED AS DOING WELL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071392 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZLB00 05050474560758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention