BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 19354728 · Received May 20, 2024

    Report

    Report Number
    3012236936-2024-000141
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 12, 2024
    Report Date
    May 20, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558373
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A6: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION D6A: IF IMPLANTED; GIVE DATE: N/A. THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A. THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. SECTION E1:TELEPHONE NUMBER: (B)(4). SECTION E1: FULL NAME, ADDRESS, EMAIL AND ZIP CODE NOT PROVIDED AS EVENT WAS REPORTED VIA THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA). SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED FROM NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT IOL WAS IMPLANTED INTO THE PATIENT'S EYE AND IT WAS FOUND THERE WAS A CRACK IN THE OPTICAL PART OF THE LENS. THE LENS WAS REMOVED AND REPLACED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452533 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose