BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_CARTRIDGE_EMERALD_UNKNOWN

    MDR report key: 11742879 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07692
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    February 17, 2021
    Report Date
    May 26, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474501805
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT INITIAL MDR REPORT (2648035-2021-07692), WAS INADVERTENTLY SUBMITTED AGAINST THE AR40M INTRAOCULAR LENS. HOWEVER, PER REPORTED DEVICE CODE THE CORRECT REPORTABLE SUSPECT PRODUCT WAS THE EMERALDC CARTRIDGE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: SECTION D1: BRAND NAME: UNK_CARTRIDGE_EMERALD_UNKNOWN SECTION D2: TYPE OF THE DEVICE: COMMON DEVICE NAME: UNFOLDER CARTRIDGE SECTION D2: TYPE OF THE DEVICE: DEVICE PRODUCT CODE: KYB SECTION D4: MODEL NUMBER: EMERALD C30 SECTION D4: LOT NUMBER: UNKNOWN/NOT PROVIDED SECTION D4: UNIQUE ID NUMBER: (B)(4). UNKNOWN SECTION D4: EXPIRATION DATE: UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED. SECTION D6: IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. SECTION D7: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. SECTION D10: CONCOMITANT PRODUCT: AR40M, SERIAL NUMBER (B)(6). SECTION H4: MANUFACTURE DATE: UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL DATA: IT WAS CONFIRMED THAT THE SUSPECT CARTRIDGE HAS NOT BEEN RETURNED BY THE ACCOUNT. SECTION H3:81 - OTHER: THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE ACCOUNT; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING 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. SEE H10 FOR EXPLANATION.

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A AR40M MODEL INTRAOCULAR LENS(IOL) WAS PARTIALLY INSERTED AND GOT STUCK IN THE CARTRIDGE. THE IOL HAD TO BE CUT OUT DURING THE SAME PROCEDURE. THIS EVENT WAS OBSERVED WHILE INSERTING THE LENS INTO THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. PATIENT RECOVERED FINE AFTER THE SURGERY . NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632832 UNK_CARTRIDGE_EMERALD_UNKNOWN UNFOLDER CARTRIDGE KYB AMO PUERTO RICO MFG. INC. EMERALDC30 UNKNOWN 05050474501805

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR AR40M, SERIAL NUMBER (B)(6).| EMERALD INSERTER