BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 11905654 · Received May 29, 2021

    Report

    Report Number
    2648035-2021-07898
    Event Type
    Malfunction
    Date Received
    May 29, 2021
    Date of Event
    May 3, 2021
    Report Date
    September 30, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620575
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9 DEVICE AVAILABLE FOR EVALUATION? : YES SECTION D9 RETURNED TO MANUFACTURER : 28 JUN 2021 SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: ONLY THE PARTICLE WAS RETURNED FOR INVESTIGATION. THE PARTICLE WAS SENT TO EUROFINS EAG LABORATORIES FOR FURTHER ANALYSIS. EAG LAB RESULTS: THE PURPOSE OF THIS ANALYSIS WAS TO IDENTIFY FOD INSIDE A PACKAGE TRAY. THE FOD WAS IDENTIFIED AS A TITANIUM ALUMINUM VANADIUM (TIALV) ALLOY. PRODUCT INVESTIGATION WAS EVALUATED WITH SME (SUBJECT MATTER EXPERT) TO ADDRESS THE COMPLAINT ISSUE REPORTED. AN EVALUATION WAS PERFORMED TO MANUFACTURING INSTRUCTIONS M1940, NSMARTLOAD DELIVERY TECHNOLOGY ASSEMBLY INSTRUCTIONS", AND THE PROCESSING AIDS (TOOLS) AND COMPONENTS USE AS PART OF THE ASSEMBLY PROCESS OF THE DEVICE. HOWEVER, NONE OF THE PROCESSING AIDS/COMPONENTS MATERIAL OR ACRYLIC IOL COMPOSITION MATCHES THE FM COMPOSITION IDENTIFIED BY THE EXTERNAL LABORATORY. IN ADDITION, THROUGHOUT THE MANUFACTURING PROCESS THERE ARE VARIOUS PROCESS CONTROLS STEPS THAT ARE ESTABLISHED TO IDENTIFY AND DISCARD AN IOL WITH ((DC-FOREIGN MATERIAL - LOOSE". THE LENS AND THE FINAL ASSEMBLED DEVICE GO THROUGH A VISUAL INSPECTION FOR PARTICULATES AND/OR FIBERS PER AMOS3016, ((PARTICLE & FIBER SPECIFICATION FOR POUCHES AND TRAYS". ACCEPTABLE UNITS CONTINUE THE MANUFACTURING PROCESS TO PRIMARY PACKAGING WHERE VISUAL INSPECTION IS PERFORMED FOR PARTICLES/FIBERS, STERILIZATION, AND THEN FINAL PACKAGING WHERE A VISUAL INSPECTION IS ALSO PERFORMED. BASED ON THE FOREIGN MATERIAL RESULTS AND THE MANUFACTURING CONTROLS IN-PLACE, IT CANNOT BE CONCLUDED THAT THE FOREIGN MATERIAL OBSERVED IS RELATED TO THE MANUFACTURING PROCESS. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED ONE ADDITIONAL COMPLAINT RECEIVED FROM THIS PRODUCTION ORDER. FILE HOWEVER WAS VOIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS LENS REMAINS IMPLANTED. INITIAL REPORTER EMAIL ADDRESS AND TELEPHONE NUMBER: UNKNOWN/NOT PROVIDED. THE DEVICE IS NOT RETURNING FOR EVALUATION AS LENS REMAINS IMPLANTED; 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF WIRE CAME WITH THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE THREAD HAS BEEN SAVED. IT WAS LEARNED THAT THE LENS IS IMPLANTED IN THE EYE, NO PATIENT INJURY EVERYTHING LOOKS FINE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801956 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620575

    Patients

    Seq Age Sex Outcome Treatment
    1