BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20298329 · Received September 25, 2024

    Report

    Report Number
    3012236936-2024-000262
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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: UNKNOWN/NOT PROVIDED SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THE IOL WAS EXPLANTED. SECTION H4 DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: 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 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 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 REGARDING THE JOHNSON AND JOHNSON (JNJ) PRELOADED INTRAOCULAR LENS (IOL) THAT THE HAPTIC BECAME STUCK TO THE OPTIC. THE SURGEON HAD TO PEEL THE HAPTIC FROM THE OPTIC USING A MALONEY (IOL MANIPULATOR INSTRUMENT), WHILE HOLDING THE LENS BACK WITH A SECOND INSTRUMENT. THE LENS REMAINS IMPLANTED. THE PATIENT WAS NOT INJURED. THE SURGEON IMPLANTED TWO DIB00 21.0 DIOPTER LENSES ON TWO SEPARATE PATIENTS, USING THE SAME POWER AND STATED THAT THIS HAS HAPPENED ONE TIME PRIOR, POSSIBLY WITH THE SAME DIOPTER POWER. NO FURTHER INFORMATION WAS PROVIDED. NOTE. THIS REPORT CAPTURES THE "PRIOR" EVENT. THE OTHER TWO EVENTS ARE BEING SUBMITTED IN 3012236936-2024-0002623 AND 3012236936-2024-0002624.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199669 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown