BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATARACT (ACCTG)201

    MDR report key: 11959389 · Received June 8, 2021

    Report

    Report Number
    1423537-2021-00639
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    November 18, 2020
    Report Date
    November 24, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLASS=SUPPLEMENTAL REPORT BEING FILED SINCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE FOLLOWING THE NARRATIVE CORRECTED DATA REGULATORY ATTACHMENTS SUBMISSION OF THE INITIAL MDR PREVIOUSLY SUBMITTED ON 11-JUN-2021.  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. 240 KITS WERE PRODUCED IN WORK ORDER #(B)(4). 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. 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 SAMPLE PICTURE PROVIDED FOR EVALUATION SO TRUE ROOT CAUSE UNKNOWN. CAPA-JRZ-01906 ADDRESSES THIS QUALITY ISSUE.  ACTION PLAN:  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. A TRAINING WAS PROVIDED TO REINFORCE PROCESSES TO PREVENT REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT BEING FILED SINCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE FOLLOWING THE SUBMISSION OF THE INITIAL MDR. 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 # (B)(4). THIS WORK ORDER WAS MANUFACTURED ON 2/17/2021. THE PRODUCTION TEAM INSPECTED EVERY (B)(4) 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. 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 SAMPLE PICTURE PROVIDED FOR EVALUATION SO TRUE ROOT CAUSE UNKNOWN. CAPA-JRZ-01906 ADDRESSES THIS QUALITY ISSUE. WE SPOKE WITH THE SEALING OPERATOR ABOUT THE COMPLAINT AND THE SEALING PROCESS, TO REINFORCE THIS OPERATION, THE OPERATOR WAS ASKED TO CHECK THE SEAL OF EACH PACKAGE TO BE COMPLETELY SEALED. WE ARE GOING TO REINFORCE THE SEALING PROCEDURES TO BE FOLLOWED BY THE SEALING OPERATOR TO PREVENT THIS TO HAPPEN IN THE FUTURE. WE WILL CONTINUE TO MONITOR FOR 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

    PATIENT REPORTED THAT THEY HAVE HAD A FEW EYE INFECTIONS DURING THE TIME THEY HAVE USED THE CATARACT PACK SEY24ACCTH FROM LOT NUMBER 57789. 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 6 DAYS POST-OP REQUIRING ANTIBIOTIC TREATMENT FROM A RETINAL SPECIALIST. THEY 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
    850360 CATARACT (ACCTG)201 EYE TRAY OJK MEX03 MEXICO-JUAREZ PRESOURCE SEY24ACCTH 577589 10885425988136

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other