BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 19459986 · Received June 4, 2024

    Report

    Report Number
    2523835-2024-01205
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 1, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00000000000000
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF BLUNT; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION WAS PROVIDED; THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, AN OPHTHALMIC KNIFE WAS FOUND BLUNT PRIOR TO PATIENT CONTACT. SURGERY WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652871 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU 00000000000000

    Patients

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