BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7388898 · Received April 2, 2018

    Report

    Report Number
    2648035-2018-00440
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    February 22, 2018
    Report Date
    June 20, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: UNKNOWN, NOT PROVIDED. EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI#): UNKNOWN, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. DEVICE MANUFACTURE DATE: UNKNOWN, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR, THE FOLLOWING SECTIONS WERE INADVERTENTLY NOT POPULATED CORRECTLY OR WERE NOT POPULATED AS REQUIRED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. PMA/510(K) #: THE CORRECT PMA NUMBER IS K081545. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON VISION SURGICAL, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT PERTAINS TO 1MTEC30 CARTRIDGE; DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL 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: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION, THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE THROUGH THE INCISION, UNFOLDED HALF WAY AND DID NOT DEPLOY. REPORTEDLY, THE SURGEON REMOVED IT AND DECIDED TO USE A NEW LENS (SAME MODEL AND DIOPTER). NO INCISION ENLARGEMENT, NO COMPLICATIONS AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230936 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON AND JOHNSON SURGICAL VISION, INC. 1MTEC30 UNKNOWN 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1