BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LANCE KNIVES

    MDR report key: 19124213 · Received April 17, 2024

    Report

    Report Number
    2523835-2024-00662
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 1, 2024
    Report Date
    November 19, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF BLUNT LANCES; 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. 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. 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

    TWENTY FIVE OPENED KNIVES, BLADES NOT PROPERLY IN SHEATHING WITH BLADES EXPOSED, IN A BAG WERE RECEIVED FOR THE REPORT OF BLUNT LANCES. SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING. SAMPLE 4, 8 AND 9 - BLADES HAD DAMAGED CUTTING EDGE. SAMPLE 1-3, 5-7 AND 10-20 - BLADES HAD BENT TIP. SAMPLE 21-25 - BLADES HAD DAMAGED CUTTING EDGE AND BENT TIPS. FUNCTIONAL PENETRATION TESTING WAS NOT PERFORMED DUE TO DAMAGED TO THE RETURNED SAMPLES. 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. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION PERFORMED. THE DAMAGE TO THE RETURNED SAMPLES IS CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS A HARD SURFACE SUCH AS THE PROTECTIVE BLADE TRAY WHEN PRODUCT IS IMPROPERLY REMOVED OR INSERTED AFTER USE, OR IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT DURING SURGERY OR SET-UP. THE DAMAGE SEEN ON THE RETURNED COMPLAINT SAMPLE COULD HAVE CONTRIBUTED TO THE CUSTOMERS REPORTED ISSUE OF BLUNT BLADES. THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE SAMPLE IS UNKNOWN, THEREFORE SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. A NONCONFORMANCE INVESTIGATION WAS COMPLETED TO INVESTIGATE THE TREND IDENTIFIED FOR DULL CUTTING INSTRUMENTS. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY NONCONFORMANCE, SUCH AS THE DAMAGED TIP AND DAMAGED CUTTING EDGE EXHIBITED ON THE RETURNED OPENED SAMPLE, IS REMOVED FROM THE LOT AND SCRAPPED. FUNCTIONAL PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. 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 HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, OPHTHALMIC KNIVES WERE FOUND TO BE DULL. THE SURGERY DETAILS WERE NOT REPORTED. THERE WAS PATIENT CONTACT, BUT NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION (IOL) SURGERY, OPHTHALMIC KNIVES WERE FOUND TO BE DULL. THE SURGERY DETAILS WERE NOT REPORTED. THERE WAS PATIENT CONTACT, BUT NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856547 V-LANCE KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 164WWX 00000000000000

    Patients

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