BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 8634839 · Received May 23, 2019

    Report

    Report Number
    2648035-2019-00591
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    April 24, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    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.  CONCOMITANT MEDICAL PRODUCTS: PLATINUM 1 INSERTER SERIAL NUMBER UNKNOWN/NOT PROVIDED, ZXR00 INTRAOCULAR LENS SERIAL NUMBER (B)(4). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS WAS CONDUCTED AND REVEALED NO ADDITIONAL INVESTIGATION REQUEST RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IMPLANTING THE LENS THE PHYSICIAN EXPERIENCED AN UNUSUAL RESISTANCE WITH THE CARTRIDGE AND INJECTOR. ONCE THE LENS WAS IN IMPLANTED IN THE EYE, THE PHYSICIAN OBSERVED A SMALL PIECE OF PLASTIC MATERIAL REMAINING IN THE EYE. IT WAS REMOVED WITHOUT ANY IMPACT TO THE PATIENT. REPORTEDLY THE PLASTIC FOREIGN BODY WAS IN THE CARTRIDGE. THE SYMFONY IOL APPEARED NORMAL. NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431853 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 CD04450 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1