BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_CARTRIDGE_PLATINUM_UNKNOWN

    MDR report key: 11868043 · Received May 22, 2021

    Report

    Report Number
    2648035-2021-07775
    Event Type
    Malfunction
    Date Received
    May 22, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 21, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE.  IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE.  THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISCARDED. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ADVANCED ONLY HALFWAY AND DID NOT ADVANCE ANY FURTHER WHEN DOCTOR BEGAN TO ADVANCE THE IOL INTO PATIENT'S RIGHT EYE. IT WAS OBSERVED THAT THE PLUNGER HAD PENETRATED THE CARTRIDGE UNDER THE IOL. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PLUNGER WENT UNDER THE IOL IN THE CARTRIDGE AFTER IT HAD INSERTED THE IOL HALFWAY INTO THE PATIENT'S EYE AND THE PLUNGER HAD PENETRATED THE BOTTOM OF THE CARTRIDGE. THE CARTRIDGE HAD A HOLE FROM THE PLUNGER ON THE BOTTOM ABOUT 4MM FROM THE TIP. THE LENS WAS 50% IN THE EYE AND 50% OUT OF THE EYE INCLUDING THE CARTRIDGE TIP AND WOULD NOT ADVANCE ANY FURTHER. THE INCISION WAS ENLARGED AND A NEW LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED WITHOUT ANY ISSUES. THERE WAS NO INJURY AND NO OTHER MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE HAD A DELAY OF 10 MINUTES AND THE PATIENT HAD FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764445 UNK_CARTRIDGE_PLATINUM_UNKNOWN UNFOLDER PLATINUM 1 SERIES KYB AMO PUERTO RICO MFG. INC. 1MTEC30 UNKNOWN 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR