BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 19085215 · Received April 10, 2024

    Report

    Report Number
    3012236936-2024-00976
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Report Date
    January 10, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474654884
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A FIBER WAS RECEIVED TAPED TO GAUZE AND WAS FORWARDED TO A THIRD PARTY LABORATORY FOR FOREIGN MATERIAL ANALYSIS. NO VITAN HANDPIECE WAS RECEIVED FOR EVALUATION. THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE MATERIAL WAS IDENTIFIED AS A TITANIUM ALLOY (E.G., TI-6AL-4V) WITH TRACE LEVELS OF SODIUM (NA) AND IRON (FE). THE INSERTER USED WITH THE SMARTLOAD DEVICE TO INJECT THE LENS IS COMPOSED OF TITANIUM; HOWEVER, THE INSERTER WAS NOT RETURNED FOR EVALUATION. UNUSED SAMPLES OF AN UNFOLDER VITAN INSERTER (LOT 0015) AND LAMINAR FLOW PHACO TIP, 21 GAUGE STRAIGHT TIP (LOT 5062516) WERE PROVIDED TO THE LABORATORY FOR MATERIAL CHARACTERIZATION TO ESTABLISH BASELINE COMPOSITION OF THE CONSUMABLES THAT MAY BE USED IN COMBINATION WITH THE SMARTLOAD. BOTH UNITS WERE ANALYZED AND CONFIRMED ALL SAMPLES ANALYZED FOR THE UNUSED INSERTER AND PHACO TIP WERE CONSISTENT WITH A TITANIUM ALLOY CONSISTENT WITH TI-6AL-4V OR TI64. A REVIEW OF THE RESULTS FOR THE RETURNED FIBER, UNUSED UNFOLDER VITAN INSERTER, AND LAMINAR FLOW PHACO TIP CONCLUDED THAT THE SOURCE OF THE FOREIGN MATTER CANNOT BE CONFIRMED AS THERE ARE MULTIPLE POTENTIAL SOURCES OF TITANIUM ALLOY IN THE SURGERY. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. 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: 29-MAY-2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A FIBER TAPED TO GAUZE WAS RECEIVED FOR FOREIGN MATERIAL ANALYSIS. THE MATERIAL WAS IDENTIFIED AS A TITANIUM ALLOY. THE INSERTER USED WITH THE SMARTLOAD DEVICE TO INJECT THE LENS IS COMPOSED OF TITANIUM; HOWEVER, THE INSERTER WAS NOT RETURNED FOR EVALUATION. THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 SURGEON OBSERVED A METAL SPLINT BEING INJECTED INTO THE PATIENT'S EYE AT THE SAME TIME AS THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED. THE SPLINT WAS REMOVED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775742 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown