BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25G BI-B POSTERIOR ELITE W WF

    MDR report key: 24225370 · Received January 30, 2026

    Report

    Report Number
    0001920664-2026-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 9, 2026
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770059775
    PMA / PMN Number
    K170052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: B1: MALFUNCTION. D4: (B)(4). H4: SEPTEMBER 17 2025. H6: HEALTH EFFECT CLINICAL CODE 4582.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION FOUND THE NEEDLE IS BENT. THE PORT WINDOW IS IN THE OPENED POSITION. THERE ARE DRIED SOLUTIONS VISIBLE AROUND THE PORT AND ON THE OUTER NEEDLE SHAFT. THERE IS SOLUTION VISIBLE IN THE ASPIRATION LINE. THE BACK CAP IS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DAMAGE WAS FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS ELITE SYSTEM. THE CUTTER HAD GOOD CLEAN CUTS THROUGHOUT THE VARIOUS CUT RATES AND HAD GOOD ASPIRATION. THIS CUTTER PERFORMED AS INTENDED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE CUTTER WAS NOT CUTTING, YET WAS STILL ASPIRATING, DURING THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288593 25G BI-B POSTERIOR ELITE W WF UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB SE5425WVB X8580 00757770059775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown