BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18332504 · Received December 14, 2023

    Report

    Report Number
    3012236936-2023-03082
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 17, 2023
    Report Date
    January 24, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474726833
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BASED ON FURTHER REVIEW, THE REPORTED ISSUE WAS REASSESSED AS NOT REPORTABLE AS THE LENS WAS REPORTED STUCK IN CARTRIDGE. THE LENS DAMAGE WAS THE CONSEQUENCE OF HANDLING AND MANUALLY REMOVING THE STUCK LENS FROM THE CARTRIDGE AFTER THE USER DECIDED TO DISCONTINUE LENS IMPLANTATION WHICH IS NOT A PRODUCT MALFUNCTION. HENCE, THE CODE FROM THE INITIAL MDR "1069 - BREAK" IS NO LONGER APPLICABLE. THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2023-03082. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: 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)(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. 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

    IT WAS REPORTED THE OPERATOR INSERTED THE OVD INTO THE CARTRIDGE AND IMPLANTED IT BUT THE FRONT HAPTIC CAME OUT OF THE CARTRIDGE HOLE AND GOT STUCK DURING THE IOL DELIVERY PROCESS, SO THE OPTIC AND REAR HAPTIC COULDN'T COME OUT. IT WAS GIVEN OVD AGAIN, BUT IT STILL COULDN'T COME OUT. THE OPERATOR REMOVED THE CARTRIDGE FROM THE INJECTOR AND ATTEMPTED TO REMOVE THE IOL USING FORCEPS. WHEN THE IOL CAME OUT, THE HAPTIC AND OPTIC HAD CRACKS. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS OF THE SAME MODEL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204287 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474726833

    Patients

    Seq Age Sex Outcome Treatment
    1 Male