BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT INTREPID KNIVES

    MDR report key: 19115293 · Received April 16, 2024

    Report

    Report Number
    2523835-2024-00658
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 17, 2024
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00380659924453
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF DULL BLADES; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBERS, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND THE DEVICE HISTORY RECORD REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THEREFORE; THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. 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).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL DETAILS RECEIVED REPORTING THAT THE ISSUE HAPPENED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695078 CLEARCUT INTREPID KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 16AM3J 00380659924453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CUSTOM-PAK SURGICAL PROCEDURE PACK