BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER EMERALD

    MDR report key: 12997418 · Received December 14, 2021

    Report

    Report Number
    3012236936-2021-00261
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 11, 2021
    Report Date
    April 6, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    15050474500126
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: SECTION D4: MODEL NUMBER: (B)(4). SECTION D4: LOT NUMBER: 4-026. SECTION D4: UDI #: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: PHOTOS OF THE DEVICE WERE REVIEWED BY THE EXTERNAL MANUFACTURER. PARTS WERE NOT RETURNED FOR FUNCTIONAL REVIEW, BUT PHOTOS SUPPLIED BY THE CUSTOMER WERE REVIEWED BY QUALITY PERSONNEL WITH NO REPORTABLE FINDINGS AS THE TIP DOES NOT APPEAR TO BE BENT AS INITIALLY REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE HANDPIECE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE HANDPIECE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. CONCOMITANT MEDICAL PRODUCTS: AR40E SENSAR LENS, SN: (B)(4), EMERALDC30 CARTRIDGE, LOT: CJ17494. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE HAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE LOT NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON TRIED TO IMPLANT THREE (3) DIFFERENT 3-PIECE INTRAOCULAR LENSES (IOL) USING AN EMERALD INTRODUCER AND IN ALL CASES, HAPTICS KEPT BENDING WHEN INTRODUCING INTO THE CARTRIDGE TIP, PRIOR TO IMPLANTATION. THE SURGEON ASSUMES THE INTRODUCER TO BE BENT AND FAULTY. THE CARTRIDGE TIP WAS IN CONTACT WITH THE EYE. THE ISSUE WAS FIRST IDENTIFIED DURING IMPLANTATION/ APPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE EVENT WHICH THE LENS WAS FULLY INSERTED IN THE PATIENT'S EYE, THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER TWO EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892868 UNFOLDER EMERALD LENS, GUIDE, INTRAOCULAR KYB JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDAR 4-026 15050474500126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown