BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM, HANDPIECE TIP

    MDR report key: 21838851 · Received April 15, 2025

    Report

    Report Number
    2523835-2025-00464
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION 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 PHOTOS ATTACHED WERE REVIEWED BY THE MANUFACTURING SITE. PHOTO 1 SHOWS A PHACO TIP BROKEN AT THE ASPIRATION BYPASS (AB) HOLE. PHOTO 2 SHOWS THREE BROKEN PHACO TIPS AT THE AB HOLE, ONE BELONGS TO QS# 2761163, ONE BELONGS TO QS# 2761173, AND ONE BELONGS TO THIS FILE. THE REPORTED ISSUE IS CONFIRMED. THE PHOTOS ATTACHED CONFIRM THE BROKEN PHACO TIP; HOWEVER, 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. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL PHACO TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS USING 30X MAGNIFICATION DURING THE MANUFACTURING PROCESS. 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).

    Description of Event or Problem · 0

    A NURSE REPORTED THAT TIP BROKE INSIDE PATIENT'S EYE DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TIP WAS REMOVED FROM THE PATIENTS EYE WITHOUT HARMING THE PATIENT. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114275 CENTURION VISION SYSTEM, HANDPIECE TIP UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 16RWY6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female