BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    MDR report key: 13635589 · Received March 1, 2022

    Report

    Report Number
    0001920664-2022-00026
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY WAS REVIEWED AND FOUND TO MEET MANUFACTURING SPECIFICATIONS. THIS INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE VACUUM PUMP HAS BEEN EVALUATED AND THE REPORTED ERROR WAS CONFIRMED. THE PUMP WAS NOT RESPONDING TO ANY COMMAND FROM CAN TOOL. ROTARY VANES CAN BE MOVED MANUALLY BUT DO NOT MOVE AT ALL WHEN COMMANDS ARE GIVEN FROM CAN TOOL. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Additional Manufacturer Narrative · 0

    G4: CORRECTED FROM K170052 TO K063331.

    Description of Event or Problem · 0

    THE USER FACILITY IN (B)(6) REPORTED THE SURGEON WAS UNABLE TO COMPLETE THE CATARACT PROCEDURE DUE TO A PROBLEM WITH THE COMPRESSOR. DURING THE FRAGMENT MODE, THE VACUUM CONTROL PUMP STOPPED WORKING AND ERROR MESSAGE APPEARED AND A SECOND SURGERY WAS REQUIRED THAT DAY. THE PATIENT WAS TRANSFERRED BY AMBULANCE TO ANOTHER HOSPITAL FOR SURGERY IN THE AFTERNOON BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199039 STELLARIS ELITE VISION ENHANCEMENT SYSTEM UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL2380 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention