BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20482383 · Received October 18, 2024

    Report

    Report Number
    3012236936-2024-000275
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746657
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: SEPT 03,2024. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE PLUNGER ROD WAS PARTIALLY ADVANCED. THE LENS WAS STUCK IN THE CARTRIDGE TIP AND THE CARTRIDGE TIP WAS CRACKED, EXTENDING INTO THE CARTRIDGE TUBE. VISCOELASTIC RESIDUE WAS DISTRIBUTED THROUGH THE LENGTH OF THE CARTRIDGE. THE LENS MODULE WAS INSPECTED, PRESENTING WITH NO VISCOELASTIC RESIDUE OR DAMAGE. DEVICE ASSEMBLY WAS INSPECTED AND PRESENTED WITH NO ISSUES. THE PLUNGER ROD ADVANCEMENT WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) CARTRIDGE BROKE DURING LENS INJECTION. THE SURGEON USED BACKUP LENSES AND THE CARTRIDGE TIP CAME INTO CONTACT WITH THE PATIENT. NO INJURIES OR MEDICAL INTERVENTIONS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959931 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown