BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7398189 · Received April 4, 2018

    Report

    Report Number
    2648035-2018-00458
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 5, 2018
    Report Date
    July 27, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MARK ON LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS REMAINS IMPLANTED, WHICH IT IS NOT AVAILABLE FOR EVALUATION. HOWEVER, TWO PHOTOS WERE ATTACHED IN THE COMPLAINT FOLDER (CF). THE PHOTOS WERE ANALYZED AND APPEARED TO BE A SCRATCH IN THE OPTIC. BASED ON THE PHOTOS, THE REPORTED COMPLAIN WAS CONFIRMED, BUT A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA/ADDITIONAL INFO: THE INITIAL REPORT 2648035-2018-00458 WAS INADVERTENTLY SUBMITTED AGAINST THE INTRAOCULAR LENS; HOWEVER, IT SHOULD HAVE BEEN FILED AGAINST THE CARTRIDGE AS THE CUSTOMER SUSPECTS THE CARTRIDGE CAUSED DAMAGE TO THE LENS. BRAND NAME: PLATINUM 1 SERIES. PRODUCT CODE: KYB - SURGICAL ADJUNCTS, MODEL #: 1MTEC30, LOT #: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 06/06/2018. PMA/510(K) #: K081545. MANUFACTURING DATE: UNKNOWN/NOT PROVIDED AS LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE RETURNED SAMPLE WAS RECEIVED IN A PLASTIC BAG. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED LUBRICANT MATERIAL RESIDUE ON THE CARTRIDGE TUBE. ALSO STRESS MARKS WERE OBSERVED ON THE CARTRIDGE TUBE, WHICH ARE TYPICALLY CAUSED AND/OR MAY WELL APPEAR BY THE PASS OF THE INTRAOCULAR LENS (IOL) THROUGH THE CARTRIDGE. THERE WAS NO DAMAGE/DEFECT OBSERVED ON THE CARTRIDGE THAT CAN CAUSE DAMAGE TO THE LENS. THE REPORTED ISSUE WAS NOT VERIFIED. BASED ON THE ANALYSIS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION, RESULTS 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

    PER FOLLOW UP, THE ISSUE IS BELIEVED TO HAVE BEEN CAUSED BY THE CARTRIDGE AND/OR THE INSERTER. THE DOCTOR HASN'T HEARD ANYTHING FROM PATIENTS REGARDING VISION ISSUES. FIELDS HAVE BEEN UPDATED AS FOLLOWS: CONCOMITANT MEDICAL PRODUCTS: UNFOLDER PLATINUM SERIES 064 D&K (LOT IS UNKNOWN), UNFOLDER PLATINUM SERIES 063 D&K(LOT IS UNKNOWN). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MARK ON LENS OPTIC EDGE. THE LENS IS NOT AVAILABLE FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239834 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1