BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 19732648 · Received July 12, 2024

    Report

    Report Number
    3012236936-2024-000174
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 18, 2024
    Report Date
    January 10, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620759
    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

    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 D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION (THE FOREIGN MATERIAL WAS NOT RETURNED AND THE LENS REMAINS IMPLANTED). 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 OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE FIBER THAT WAS RECEIVED LOOSE IN A BAG. FOREIGN MATERIAL EVALUATION REVEALED THAT THE MATERIAL IS PRIMARILY A TITANIUM ALLOY, WITH TRACE LEVELS OF SALTS. NO FURTHER EVALUATION WAS PERFORMED. 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 16-JUL-2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE FIBER THAT WAS RECEIVED LOOSE IN A BAG. FOREIGN MATERIAL EVALUATION REVEALED THAT THE MATERIAL IS PRIMARILY A TITANIUM ALLOY, WITH TRACE LEVELS OF SALTS. NO FURTHER EVALUATION WAS PERFORMED. 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 A THIRD PARTY 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 LABORATORY 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. 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 SAW A METAL SPLINTER BEING INJECTED INTO THE EYE AT THE SAME TIME AS THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED. THE SPLINTER WAS REMOVED FROM THE EYE. NO FURTHER INFORMATION ABOUT PATIENT COMPLICATIONS WERE RECEIVED. THE LENS REMAINS FULLY IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142789 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose