BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 24511017 · Received March 4, 2026

    Report

    Report Number
    1644019-2026-01257
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    October 28, 2025
    Report Date
    March 4, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657522002
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. 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 PHOTO ATTACHED TO THE COMPLAINT WAS REVIEWED BY THE MANUFACTURING SITE. THE PHOTO 1 SHOWS PHACOEMULSIFICATION (PHACO) TIPS AND WRENCH AND PHOTO 2 SHOWS LISTS OF PAK LOT NUMBER ASSOCIATED WITH THIS QS AND OTHER QSS. REPORTED ISSUE CANNOT BE CONFIRMED FROM PHOTOS. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION DURING THE MANUFACTURING PROCESS. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL COMPANY 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.

    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.

    Description of Event or Problem · 0

    A NURSE REPORTED THAT BENT TIP AT AN UNKNOWN TIMING. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY COMPLETION AND REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568334 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17CV19 00380657522002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown