BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17591633 · Received August 21, 2023

    Report

    Report Number
    3012236936-2023-02129
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 21, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655447
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: DATE OF BIRTH WAS PROVIDED AS AAE8848. SECTION A4: PATIENT WEIGHT: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION A5: ETHNICITY: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION A5: RACE WAS PROVIDED AS EUROPEAN, NEWZEALANDER. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: REPORTER: TELEPHONE NUMBER:(B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TECNIS SIMPLICITY TECNIS EYHANCE MONOFOCAL INTRAOCULAR LENS (IOL) DID NOT ENGAGE IN THE NOZZLE PROPERLY AND DID NOT DEPLOY IN THE PATIENT LEFT EYE. WHEN TAKEN OUT IT CRACKED AT THE NOZZLE WHEN TRYING TO DEPLOY THE LENS. ADDITIONAL INFORMATION STATED THAT THE CARTRIDGE TIP HAD A CONTACT WITH EYE. REPORTEDLY THERE WAS NO USE ERROR. COMBINATION OF BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM ANOTHER MANUFACTURER WAS USED FOR CARTRIDGE LUBRICATION AT A ROOM TEMPERATURE. THE AVERAGE DWELL TIME WAS AROUND 3-4 MINUTES. INITIAL ADVANCEMENT WAS DONE THROUGH PUSH. NURSE PERFORMED THE INITIAL MOVEMENT OF THE LENS. WHEN ADVANCING THE LENS A SMALL 1/4 TWIST WAS MADE. THE PROCEDURE WAS COMPLETED USING SAME MODEL ANOTHER BACK UP LENS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851600 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female