BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SURGICAL PROCEDURE PAK

    MDR report key: 21839904 · Received April 15, 2025

    Report

    Report Number
    1644019-2025-01025
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B.5, H.8. H.11. ADDITIONAL INFORMATION REPORTED THAT THE PHACOEMULSIFICATION TIP WAS REUSED. 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 PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT; 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 INVESTIGATION SITE AND NO LOT INFORMATION IS AVAILABLE, 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. 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). 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

    ADDITIONAL INFORMATION REPORTED THAT THE PHACOEMULSIFICATION TIP WAS REUSED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT THE BALANCED ENERGY PHACOEMULSIFICATION TIP BROKEN DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133334 CENTURION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown