BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 23641038 · Received November 25, 2025

    Report

    Report Number
    3012236936-2025-000311
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 9, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474501867
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. 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 REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW, IT WAS DISCOVERED THIS EVENT WAS ALREADY REPORTED UNDER MANUFACTURER REPORT NUMBER #3012236936-2025-0003026. THEREFORE, THE EVENT UNDER THIS REPORT IS NO LONGER CONSIDERED REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS REPORT NUMBER: 3012236936-2025-0003114. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF PROMINENT GLARE AND HALO, WHICH RESULTED IN DIFFICULTIES WITH COMPUTER USE AND READING, AND LED TO THE PATIENT'S INABILITY TO PERFORM ONE OR MORE DAILY ACTIVITIES FOLLOWING SURGERY. AT A POST-OPERATIVE VISIT, UNDER-CORRECTION WAS NOTED, AND THE PATIENT REQUESTED A LENS EXCHANGE. THE ORIGINAL LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH AN AR40E 5.0 IOL. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. THERE WERE NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT¿S PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467899 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474501867

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention