BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 10986699 · Received December 10, 2020

    Report

    Report Number
    2648035-2020-00921
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 11, 2020
    Report Date
    April 1, 2021
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED, THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 8 FEB, 2021. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: COMPLAINT PRODUCT WAS RETURNED IN A PLASTIC BAG. ONE OPENED CARTRIDGE WAS RECEIVED LABELED AS 1MTEC30 CARTRIDGE MODEL WITH LOT NUMBER CE10130, AND ONE EMERALD CARTRIDGE MODEL WAS INSIDE THE TRAY. THE REPORTED ISSUE WAS VERIFIED. BASED ON THE INVESTIGATION THERE IS AN INDICATION OF A POTENTIAL PRODUCT MALFUNCTION AND PRODUCT DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION (CAPA- 010465) TO INVESTIGATE AND ADDRESS THE ISSUE. JOHNSON AND JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: NOT APPLICABLE, AS THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, AS THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED ISSUES WITH 2 UNITS OF 1MTEC30. WHEN OPERATING ROOM (OR) STAFF OPENED 1MTEC30 CARTRIDGE CASE, THEY NOTICED EMERALDC30 CARTRIDGE INSIDE. NOTICED WHEN REMOVING FROM PACKAGING. NO PATIENT INVOLVEMENT REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO JOHNSON & JOHNSON VISION. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448830 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 CE10130 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1