BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_MONOFOCAL IOL

    MDR report key: 22333466 · Received June 25, 2025

    Report

    Report Number
    3012236936-2025-000176
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Report Date
    June 25, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION B3, DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D1, BRAND NAME: MONOFOCAL, EXACT BRAND IS UNKNOWN DUE TO THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4, MODEL AND CATALOG NUMBER: UNKNOWN DUE TO THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4, SERIAL NUMBER: UNKNOWN/NO INFORMATION. SECTION D4, EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4, UNIQUE IDENTIFIER (UDI) NUMBER: A PARTIAL UDI WAS PROVIDED AS THE SERIAL NUMBER IS NOT AVAILABLE. SECTION D6A IF IMPLANTED; GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE IOL WAS IMPLANTED. SECTION D6B IF EXPLANT; GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE IOL WAS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION H4, DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED. THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH 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 THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) CRACKED UPON INSERTION. NO FURTHER INFORMATION REGARDING THIS ISSUE WAS PROVIDED. HOWEVER, THE DOCTOR ALSO MENTIONED FREQUENT INSTANCES OF IOLS CRACKING DURING INSERTION AND REQUESTED GUIDANCE ON BEST PRACTICES FOR PREPARING THE TECNIS PRELOADED IOL TO ADDRESS THE ISSUE. JOHNSON AND JOHNSON CONDUCTED AN IN-SERVICE/TRAINING JUNE 18, 2025. IT WAS REPORTED THAT EVERYONE IS NOW ALIGNED. NOTE. THE MANUFACTURER REPORT NUMBER FOR THE PREVIOUS CASES (FREQUENT INSTANCES) IS 3012236936-2025-0001768.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793724 UNK_MONOFOCAL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown