BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12021764 · Received June 17, 2021

    Report

    Report Number
    2648035-2021-08008
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    September 21, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558137
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE(S) 4625 PROVIDED ON THE INITIAL REPORT NEEDS TO BE REMOVED AS IT SHOULD NOT HAVE BEEN INDICATED IN THE INITIAL REPORT. ALSO FOR HEALTH EFFECT CLINICAL CODE 4581 SHOULD BE ADDED. FIELD BELOW UPDATED: SECTION H6: HEALTH EFFECT CLINICAL CODE: 4581 (CAPTURES INCISION ENLARGEMENT). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED: 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AFTER ENTERING THE OPTIC ZONE OF THE ANTERIOR CAMARA; IT WAS OBSERVED THE SECOND HAPTIC WAS AMPUTATED, INSIDE THE CARTRIDGE OF THE IMPLANT. THEY CHOSE ON MAINTAINING THE LENS IN CAPSULAR BAG FOR LATER REPLACEMENT, AS THERE WAS NO OTHER INTRAOCULAR LENS (IOL) WITH THE SAME DIOPTER AVAILABLE AT THAT MOMENT. MEDICATION WAS PRESCRIBED (VIGADEXA). PRE-OP VISION: 20/60; POST-OP VISION: 20/70. THE EXPLANT WAS PLANNED BUT DID NOT OCCUR. INCISION WAS AMPLIFIED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913980 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention