BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOFOCAL IOL

    MDR report key: 21109987 · Received January 9, 2025

    Report

    Report Number
    3012236936-2025-000009
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 9, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: THE CUSTOMER RESPONDED AS ¿FEMALE¿. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: UNKNOWN/NOT PROVIDED. SECTION D1, BRAND NAME: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN SERIAL NUMBER. SECTION D4, MODEL: UNKNOWN DUE TO THE SERIAL NUMBER NOT BEING PROVIDED. SECTION D4, CATALOG NUMBER: UNKNOWN DUE TO THE SERIAL NUMBER NOT BEING PROVIDED. SECTION D4, SERIAL NUMBER: UNKNOWN/NOT PROVIDED. 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 LENS WAS IMPLANTED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE. THERE IS NO INDICATION THE LENS WAS IMPLANTED. THEREFORE, IT WAS NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE DEVICE WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4, DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. 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) WAS PARTIALLY INSERTED INTO THE PATIENT'S RIGHT EYE. PRIOR TO BEING FULLY INSERTED, IT WAS IDENTIFIED THAT THE HAPTIC HAD BROKEN OFF. CONSEQUENTLY, THE CUSTOMER ATTEMPTED TO USE ANOTHER IOL BUT AFTER BEING FULLY INSERTED, THE HAPTIC ALSO BROKE OFF (MANUFACTURER REPORT NUMBER 3012236936-2025-0000097). THE CUSTOMER USED ANOTHER IOL. THIS WAS THE LAST LENS, AND IT WAS SUCCESSFULLY INSERTED, IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365084 MONOFOCAL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female