BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS VISION ENHANCEMENT SYSTEM

    MDR report key: 24270146 · Received February 5, 2026

    Report

    Report Number
    0001920664-2026-00015
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 14, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770480678
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE WAS DETERMINED TO BE A COMPONENT ISSUE. THE SYSTEM, MANUFACTURED IN 2012, IS WELL INTO ITS SERVICE LIFE, AND THE FAILURE IS CONSISTENT WITH AGE-RELATED WEAR OVER TIME. 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. CORRECTION TO G4: 510K FROM K101325 TO K063331.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SERVO VALVE IS FAULTY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE USER FACILITY IN FRANCE REPORTED THAT DURING A VITRECTOMY, THE IRRIGATION WAS TOO LOW TO CONTINUE. IT WAS VERY LOW EVEN WHEN THEY SET THE IV POLE HIGHER. THE SURGEON FELT UNCOMFORTABLE AND DID NOT PROPERLY END THE VITRECTOMY SURGERY. THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440184 STELLARIS VISION ENHANCEMENT SYSTEM UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL11110 00757770480678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BL2310 (B)(6)