BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 19663384 · Received July 3, 2024

    Report

    Report Number
    2523835-2024-01604
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 5, 2024
    Report Date
    November 6, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650001597
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN D.4. AND H.11. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT MANUFACTURING SITE UPDATED DUE TO RECEIPT OF D.1., D.2., D.3., D.4., AND D.9. MANUFACTURER REPORT NUMBER CORRECTED AND REPORTED UNDER MDR# 1644019-2024-02352. ONE OPENED PHACOEMULSIFICATION TIP WITH A WRENCH WAS RECEIVED. SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING. BROKEN AT CONE TO TRANSITION AREA, BREAKAGE IS VERY JAGGED. CRACK OBSERVED ON THE CANNULA WHERE THE PART BROKE IN 2 PIECES. UNEVEN WALL THICKNESS OBSERVED. WALLS WERE OBSERVED TO BE THIN. WEAR OBSERVED ON THREADS, BACK OF FLANGE, AND NUT CORNERS CONSISTENT WITH THREADING ON HANDPIECE. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE COMPLAINT EVALUATION CONFIRMS THE PHACOEMULSIFICATION TIP IS BROKEN. THE REASON FOR BREAKAGE IS DUE TO UNEVEN WALL THICKNESS CREATING A WEAK REGION AT THE THINNER SECTION. THE UNEVEN WALL THICKNESS IS A MANUFACTURING ISSUE CREATED AT THE MACHINING PROCESS FOR THE PHACOEMULSIFICATION TIPS. AN INVESTIGATION HAS BEEN INITIATED AND IS CURRENTLY IN PROGRESS, TO FURTHER INVESTIGATE THE BROKEN PHACOEMULSIFICATION TIP. ALL PHACOEMULSIFICATION TIPS ARE 100 PERCENT VISUALLY INSPECTED BY TRAINED OPERATORS USING 30 TIMES MAGNIFICATION DURING THE MANUFACTURING PROCESS. ANY NONCONFORMANCE, SUCH AS THE FOREIGN MATERIAL IN THE PHACOEMULSIFICATION TIP CANNULA EXHIBITED ON THE RETURNED OPENED SAMPLE, IS REMOVED FROM THE LOT AND SCRAPPED. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT THE PHACO TIP WAS BROKEN DURING CATARACT SURGERY. THE BROKEN TIP WAS REMOVED WITHOUT CAUSING ANY DAMAGE. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785469 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 16DTDF 00380650001597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown