BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCUT KNIVES

    MDR report key: 24331851 · Received February 13, 2026

    Report

    Report Number
    2523835-2026-00157
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 7, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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. A SAMPLE HAS BEEN RECEIVED BY MANUFACTURING THAT HAS NOT YET BEEN EVALUATED. 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 D.9, H.3, H.6 AND H.11. ONE OPENED KNIFE WAS RECEIVED FOR THE REPORT OF KNIFE DOES NOT CUT. SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING WITH A BENT TIP AND DAMAGED CUTTING EDGE. PENETRATION TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE SAMPLE. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NONCONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. THE PHOTO WAS REVIEWED BY THE MANUFACTURING SITE THE PHOTO SHOWS KNIVES IN BLISTER ASSOCIATED WITH THIS QS AND OTHER QSS. REPORTED ISSUE CANNOT BE CONFIRMED FROM PHOTOS. THE RETURNED SAMPLE IS VISUALLY NON-CONFORMING WITH A BENT TIP AND DAMAGED CUTTING EDGE. THE DAMAGE TO THE RETURNED SAMPLE 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 KNIFE DOES NOT CUT. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. ALL KNIVES ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. FUNCTIONAL PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL MANUFACTURE PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. 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

    THE PHARMACIST REPORTED THAT A DURING SURGERY OPHTHALMIC KNIFE DID NOT CUT PROPERLY. THE SCHEDULED PROCEDURE IS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING SECOND KNIFE WITHOUT ANY PATIENT HARM. THIS REPORT PERTAINING TO FOURTH OF THE TWENTY ONE REPORTS FROM THE SAME FACILITY.

    Description of Event or Problem · 0

    THE PHARMACIST REPORTED THAT A DURING SURGERY OPHTHALMIC KINFE DID NOT CUT PROPERLY. THE SCHEDULED PROCEDURE IS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING SECOND KINFE WITHOUT ANY PATIENT HARM. THIS REPORT PERTAINING TO FOURTH OF THE TWENTY ONE REPORTS FROM THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113239 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1