BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 24139699 · Received January 21, 2026

    Report

    Report Number
    3012236936-2026-000021
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    October 21, 2025
    Report Date
    January 21, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474657861
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    . SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4613 - THIS CODE WAS USED TO CAPTURE (HALO VISION, GLARE & DISSATISFIED). ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT AFTER THE NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT HAS BEEN EXPERIENCING SEVERE POSITIVE DYSPHOTOPSIAS, DESCRIBED AS VISUAL DISTURBANCES RESEMBLING FIREWORKS, CHRISTMAS LIGHTS, FERRIS WHEELS, AND MUSHROOM LIGHTS, PARTICULARLY NOTICEABLE AT NIGHT AND AROUND LIGHT SOURCES, PUDDLES, OR SHINY OBJECTS. GLARE AND BLURRY VISION WERE ALSO REPORTED. THESE SYMPTOMS HAVE SIGNIFICANTLY IMPACTED DAILY ACTIVITIES, INCLUDING DRIVING AND NIGHTTIME OUTINGS. THE PATIENT REPORTED BEING UNABLE TO DRIVE AT NIGHT DUE TO POOR VISION. FOLLOW-UP EXAMINATIONS HAVE INDICATED NO ISSUES, AND ATTEMPTS TO ALLEVIATE THE SYMPTOMS USING BLUE LIGHT GLASSES HAVE NOT RESULTED IN IMPROVEMENT. THE PATIENT WAS INFORMED BY THE DOCTOR THAT TIME IS NEEDED FOR NEUROADAPTATION, HOWEVER THE PATIENT DOES NOT SEE ANY VISUAL IMPROVEMENTS AS TIME PASSES. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE RIGHT EYE EVENT. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE PATIENT'S LEFT EYE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202508 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCU150 05050474657861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other