BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAN

    MDR report key: 18965996 · Received March 23, 2024

    Report

    Report Number
    3012236936-2024-00645
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    February 27, 2024
    Report Date
    August 1, 2024
    Manufacturer
    DUCKWORTH & KENT
    Product Code
    MSS
    PMA / PMN Number
    K191949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: 1ST APRIL 2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED, AND NO ISSUES WERE OBSERVED WITH THE COMPLAINT SMARTLOAD. A FIBER WAS RECEIVED STUCK TO A MEDICAL GAUZE. THE FIBER WAS SENT TO EAG LABORATORIES FOR EVALUATION. PER EAG LABORATORIES, THE FOREIGN MATERIAL WAS IDENTIFIED AS A TITANIUM ALLOY (E.G. TI-6AI-4V). SEE EAG-0132392.PDF FOR FURTHER INFORMATION. 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. 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 D6B - EXPLANT DATE: NOT APPLICABLE, AS 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOWING INVESTIGATION, THE DECISION WAS MADE ON 10 JULY 2024, THAT IT WAS MORE LIKELY THE METAL FRAGMENT ORIGINATED FROM THE VITAN INSERTER, RATHER THAN THE INTRAOCULAR LENS (IOL). HENCE, WE ARE UPDATING THE SUSPECT PRODUCT IN THIS COMPLAINT FILE TO THE INSERTER USED WITH THE PRELOADED DEVICE. WE ARE SUBMITTING THIS FOLLOW UP REPORT ON OUR DEVICE DK9000 (INSERTER). SECTION D1 - BRAND NAME: VITAN ; SECTION D2A - COMMON DEVICE NAME: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) ; SECTION D2B - DEVICE PRODUCT CODE: MSS ; SECTION D3 - ESTABLISHMENT NAME: (B)(4); SECTION D3 - EMAIL ADDRESS: (B)(4); SECTION D3 - COUNTRY: UNITED KINGDOM; SECTION D3 - ADDRESS - LINE 1: 7 MARQUIS BUSINESS CENTRE; SECTION D3 - ADDRESS - LINE 2: ROYSTON ROAD; SECTION D3 -CITY: BALDOCK HERTS; SECTION D4 - MODEL NUMBER: DK9000; SECTION D4 - CATALOG NUMBER: DK9000; SECTION D4 - LOT NUMBER: UNKNOWN; SECTION D4 - EXPIRATION DATE: UNKNOWN; SECTION D4 - UDI NUMBER: (01)(10)UNKNOWN; SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE INSERTER IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE INSERTER IS NOT AN IMPLANTABLE DEVICE. SECTION G4 - PMA/510(K) NUMBER: K191949. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN. SECTION H3 - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOTL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 A METAL PART WAS DISCOVERED DURING THE IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL). ACCOUNT INDICATED THAT THE FOREIGN MATTER WAS REMOVED AND THE LENS REMAINS IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701076 VITAN FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS DUCKWORTH & KENT DK9000 UNKNOWN
    2025435 VITAN FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) MSS DUCKWORTH & KENT DK9000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown