BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATARACT (ACCTG)201

    MDR report key: 11960180 · Received June 8, 2021

    Report

    Report Number
    1423537-2021-00640
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    January 26, 2021
    Report Date
    June 18, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJK
    UDI-DI
    10885425988136
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED SINCE THE RESULTS OF INVESTIGATION ARE AVAILABLE AFTER THE INITIAL MDR WAS FILED. THE INVESTIGATION CONSISTED OF A REVIEW FROM CARDINAL'S DEVICE HISTORY RECORD VIDEO IMAGE AND THE SPECIAL INSTRUCTIONS, AS WELL AS THE PACK¿S CONFIGURATION BY THE DESIGN DEPARTMENT. (B)(4) KITS WERE PRODUCED IN WORK ORDER #577589. THIS WORK ORDER WAS MANUFACTURED ON 2/17/2021. THE PRODUCTION TEAM INSPECTED EVERY 50TH KIT AND NO DISCREPANCIES WERE FOUND. THE QUALITY ASSURANCE TEAM INSPECTED THE PACK #1 AND NO DISCREPANCIES WERE FOUND. NO NON-CONFORMANCE WAS GENERATED FOR THIS WORK ORDER. CAPAS, EVENTS, NC¿S AND COMPLAINTS ARE REVIEWED REGULARLY THROUGH VARIOUS MEANS INCLUDING, BUT NOT LIMITED TO CAPA REVIEW BOARDS, MANAGEMENT REVIEWS, COMPLAINT TRENDING REVIEWS, AND MONTHLY METRICS. COMPLAINT AND CAPA HISTORY WOULD BE INCLUDED IN ANY DISTRIBUTED PRODUCT FIELD ACTION REVIEW WHEN MAKING DECISIONS OF FIELD ACTIONS. CAPA EFFECTIVENESS CHECKS WOULD ALSO BE VERIFYING FOR RECURRING ISSUES POST CORRECTIVE ACTION. COMPLAINT HISTORY REVIEWS ARE PERFORMED FOR EACH COMPLAINT FOR THE CATALOG AND/OR COMPONENT IN QUESTION. THE ASSEMBLY PROCESS SYSTEM WAS REVIEWED, THE ELECTRONIC DEVICE HISTORY RECORD, AND THE VIDEO IMAGE. THIS WORK ORDER (B)(4) WAS MANUFACTURED IN 2/17/2021. ORDER QUANTITY (B)(4) KITS. QUALITY INSPECTED 4 KIT. THERE IS NO NON-CONFORMANCE FOR THIS WORK ORDER. THERE ARE NO SPECIAL INSTRUCTIONS ON THE AFFECTED WORK ORDER. THERE IS NO DOCUMENTED BATCH NUMBER IN THE DEVICE HISTORY RECORD (DHR). THE PRODUCTION TEAM¿S PREVIOUS WORK ORDER WAS REVIEWED TO ENSURE PROPER LINE CLEARANCE BETWEEN ORDERS; AND SHOWED NOTHING OUT OF THE ORDINARY THAT COULD HAVE CONTRIBUTED TO THE CONTAMINATION REPORTED OF LOOSE DEBRIS. THE PRODUCTION TEAM FAILED TO DETECT ANY CONTAMINATION OF THIS SORT DURING THE ASSEMBLY PROCESS. THERE WAS NO PICTURE PROVIDED FOR EVALUATION. PLEASE SEE CAPA-JRZ-02174. THE PRODUCTION TEAM WAS NOTIFIED OF THE COMPLAINT FOR HEIGHTENED AWARENESS AND REMINDED OF THE IMPORTANCE FOR INSPECTING FOR CONTAMINATION AND TO FOLLOW REGULAR CLEANING PROTOCOL. WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAVE HAD A FEW EYE INFECTIONS DURING THE TIME THEY HAVE USED THE CATARACT PACK SEY24ACCTH FROM LOT NUMBER 577589. THE SCRUBS AND RNS MET AND BRAINSTORMED AND APPARENTLY THE SCRUBS HAVE SEEN ¿PARTICLES¿ SUCH AS PLASTIC IN THE PACKS BEFORE. PATIENT DEVELOPED AN EYE INFECTION 7 DAYS POST-OP REQUIRING ANTIBIOTIC TREATMENT FROM A RETINAL SPECIALIST. CUSTOMER STATED SINCE IT HAS BEEN YEARS SINCE THEY HAVE HAD ANY COMPLICATION FROM A SURGICAL PROCEDURE, THEY ARE LOOKING AT ¿EVERYTHING¿ BUT THEY ARE UNABLE TO PINPOINT A COMPONENT THAT WAS CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850473 CATARACT (ACCTG)201 EYE TRAY OJK MEX03 MEXICO-JUAREZ PRESOURCE SEY24ACCTH 577589 10885425988136

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR