BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 7667863 · Received July 6, 2018

    Report

    Report Number
    2648035-2018-00954
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 7, 2018
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474530027
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    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(B)(4).

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: 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; THEREFORE, NOT EXPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN REVIEW OF THE INITIAL MDR 2648035-2018-00954, IT WAS NOTED THAT THERE WAS A TYPO IN SECTION - NARRATIVE. IT WAS INADVERTENTLY STATED THAT THE IOL IS NOT RETURNING, WHICH IS INCORRECT AS THE SUSPECT DEVICE IS THE CARTRIDGE. THE INFORMATION HAS BEEN CORRECTED ON THIS SUPPLEMENTAL FILING. THE CARTRIDGE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE TIP IS DAMAGED AND CRACKED. PER ACCOUNT, THE LENS HAD TO BE REPLACED BECAUSE THE INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE IN THE CARTRIDGE. REPORTEDLY, ONCE IT WAS LOADED, THE SCRUB TECH DID NOT HEAR OR SEE THAT IT HAD CRACKED AND WAS ONLY NOTICED WHEN THE SURGEON WAS TRYING TO ADVANCE THE LENS INTO THE PATIENT'S EYE. IT WAS PULLED OUT OF THE EYE AND THAT IS WHEN THEY DISCOVERED THE CARTRIDGE IS CRACKED. MOREOVER, THEY NOTICED MICRO CRACKS IN THE BARREL. PRODUCT IS NOT EXPECTED TO BE RETURNED. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THERE WAS NO SECONDARY PROCEDURE REQUIRED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS ONE (1) OF TWO (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509889 EMERALD SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDC30 CD00717 05050474530027

    Patients

    Seq Age Sex Outcome Treatment
    1