BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERALD

    MDR report key: 8093577 · Received November 21, 2018

    Report

    Report Number
    2648035-2018-01503
    Event Type
    Injury
    Date Received
    November 21, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474530027
    PMA / PMN Number
    K961242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 NR-(B)(4) AND CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BASED ON NEW INFORMATION RECEIVED, THERE WAS A 5 MINUTE DELAY IN PROCEDURE AND THERE WAS A THREADING OF THE MAIN INCISION AS INCISION ENLARGEMENT WAS PERFORMED. PRODUCT WILL NOT BE RETURNED AS IT IS DISCARDED BY THE SURGERY CENTER. THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: AGE/DATE OF BIRTH: (B)(6), SEX/GENDER: MALE. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT IS DISCARDED; 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, IT WAS NOTED THAT AN UPDATE OF INITIAL CODE (B)(4) FOR UNSPECIFIED INJURY TO INCISION ENLARGEMENT AND THAT THREADING OF THE INCISION (SUTURES) WAS NOT CAPTURED IN THE SUPPLEMENTAL MDR REPORT#1; THEREFORE, THIS INFORMATION IS BEING CAPTURED IN THIS SUPPLEMENTAL REPORT#2. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MODEL EMERALDC30 UNFOLDER CARTRIDGE HAD IRREGULAR TIP WITH NON-CYLINDRICAL EDGES AS THIS ALLEGED ISSUE WHICH CAUSED INJURY OF THE INCISION DURING SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933418 EMERALD SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDC30 05050474530027

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other