BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 10623983 · Received October 2, 2020

    Report

    Report Number
    2648035-2020-00731
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Report Date
    November 13, 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 Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION (THE DEVICE WAS DISCARDED AT THE CUSTOMER SITE). HOWEVER, THE REPORTED FOREIGN SUBSTANCE WAS RECEIVED IN A PLASTIC BAG AND ATTACHED TO A PIECE OF PAPER WITH SCOTCH TAPE. THE FOREIGN MATERIAL WAS SENT TO AN INDEPENDENT LABORATORIES FOR FURTHER ANALYSIS. BASED ON THE INDEPENDENT LABORATORY ANALYSIS, THE FOREIGN MATERIAL WAS TRANSFERRED TO AN INFRARED TRANSMITTING SUBSTRATE AND ANALYZED IN TRANSMISSION MODE USING A PERKINELMER SPECTRUM SPOTLIGHT 200 FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER EQUIPPED WITH A MICROSCOPE. THE ANALYTICAL SPOT SIZE WAS APPROXIMATELY 100 MICRONS X 100 MICRONS. PERKINELMER SPECTRUMIR SOFTWARE WAS USED TO PERFORM DATA ANALYSIS. FTIR ANALYSIS INDICATES THE FOREIGN MATERIAL IS CONSISTENT WITH POLYPROPYLENE. THE POLYPROPYLENE CAN BE ANY TYPE OF PLASTIC MATERIAL. EVALUATION OF THE MATERIALS USED AS PART OF THE COATED CARTRIDGE MANUFACTURING PROCESS WAS PERFORMED AND THE PART (CARTRIDGE, MOLDED, PLATINUM 1 SERIES) MATERIAL IS POLYPROPYLENE. SINCE THE DEVICE WAS NOT RETURNED, WITHOUT THE USED UNIT, IT CANNOT BE CONFIRMED IF THE FOREIGN MATERIAL WAS ORIGINATED FROM THE UNIT (CARTRIDGE). MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE WAS NO DISCREPANCY AND/OR DEVIATION FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE MANUFACTURING PROCESS HAS CONTROLS TO IDENTIFY AND DISCARD UNITS WITH LOOSE FOREIGN MATERIAL. THE UNITS WERE MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. PHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS WAS IMPLANTED, FOREIGN SUBSTANCES WERE OBSERVED IN THE PATIENT¿S EYE. THE SUBSTANCES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INDICATED THAT THE LENS REMAINS IMPLANTED. THERE WAS NO INTERVENTION REQUIRED. REPORTEDLY, THE CARTRIDGE WAS DISCARDED AT THE CUSTOMER SITE BUT THEY SAVED FOREIGN MATERIAL. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086330 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 CH04901 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 TORIC LENS, MODEL: ZCW225, SN: (B)(4)