BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 13216370 · Received January 11, 2022

    Report

    Report Number
    3012236936-2022-00020
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 14, 2021
    Report Date
    August 10, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474654815
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED . TELEPHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: 24TH MARCH 2022 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE GIB00 PRODUCT WAS RETURNED IN ITS ORIGINAL FOLDING CARTON PACKAGE, THE LENS WAS NOT RETURNED. THE PARTICLE RECEIVED IS PART OF THE LENS MODULE AND WAS DETERMINED TO BE ONE OF THE FOUR (4) SNAPS OF THE LENS MODULE. IN THE RETURNED SAMPLE ONE (1) SNAP WAS MISSING. TO CONFIRM THAT THE PARTICLE IS PART OF THE LENS MODULE, THE PARTICLE WAS SENT TO AN EXTERNAL LABORATORY FOR FURTHER ANALYSIS. LAB RESULTS REVEALED THAT SAMPLE IS IDENTIFIED AS POLYPROPYLENE AND CORRELATES WITH THE MANUFACTURING PROCESS FTIR LIBRARY. THEREFORE, THE PLASTIC RECEIVED WAS DETERMINED TO BE PART OF THE LENS MODULE COMPONENT. A FAILURE INVESTIGATION (FI) WAS CONDUCTED. RESIDUES OF VISCOELASTIC MATERIAL WAS OBSERVED ON CARTRIDGE AND LENS MODULE. THE CARTRIDGE TIP WAS OBSERVED DEFORMED/BENT. THE LENS MODULE WAS OBSERVED WITH SOME MARKS NEAR THE STORAGE AREA BUMPS. ONE OF THE FOUR SNAPS FEATURES OF THE LENS MODULE WAS OBSERVED BROKEN, THE OTHER NEXT TO THIS ONE WAS OBSERVED DEFORMED. THERE ARE NO MARKINGS OBSERVED AT THE BACK SIDE OF THE LENS MODULE TO INDICATE THAT THE DEVICE WAS PLACED ON A HANDPIECE BY USER. THE MANUFACTURING RECORDS REVIEW FOR THIS PRODUCTION ORDER SHOWS THAT THE UNITS WERE RELEASED WITHIN SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THE PRODUCTION ORDER WAS PERFORMED MAY 9, 2022. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. MANUFACTURING CONTROLS ARE IN PLACE AND REQUIRE THAT THE OPERATORS INSPECT THE SMARTLOAD ASSEMBLY AND REJECT UNIT IF IT IS BROKEN, PRESENTS STRESS MARKS OR HAS PARTICLES, FIBERS, OR ANY OTHER FOREIGN MATTER BEFORE LOADING IT INTO THE ASSEMBLY FIXTURE. ADDITIONALLY, DURING VISUAL INSPECTION THE OPERATORS VERIFY 100% OF THE PRELOADED DEVICES OF THE PRODUCTION ORDER TO CONFIRM THAT THE MODULE OF THE PRELOADED DEVICE IS CLOSED AND THERE IS NO PRESENCE OF FIXED AND/ OR LOOSE PARTICLES AND/ OR FIBERS IN THE DEVICE. BASED ON THE LAB RESULTS AND ANALYSIS OF THE RETURNED DEVICE, THE COMPLAINT ISSUE REPORTED WAS CONSIDERED VERIFIED AND DETERMINED AN TO BE AN ISOLATED EVENT. AWARENESS WAS CONDUCTED TO THE EMPLOYEES TO REINFORCE THE ASSEMBLY VISUAL INSPECTION DURING THIS PROCESS. THESE TYPES OF EVENTS WILL CONTINUE TO BE MONITORED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR SAW A PLASTIC SPLINTER ON THE LENS DURING LENS IMPLANTATION. THEY WERE ABLE TO REMOVE THIS SPLINTER THROUGH AN ENLARGED INCISION. THE PATIENT HAS FULLY RECOVERED. NO PATIENT INJURIES REPORTED AND THE PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. NO MEDICAL INTERVENTIONS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444562 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown