BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS VISION ENHANCEMENT SYSTEM

    MDR report key: 6175167 · Received December 15, 2016

    Report

    Report Number
    0001920664-2016-00453
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED IN THE REPORTED EVENT WAS DISPOSED AT THE FACILITY. THE CUSTOMER SAVED ONE OF THE PARTICLES HOWEVER TO DATE THE PARTICLE WAS NOT RETURNED FOR EVALUATION. THE LOT/DEVICE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A REPORT FROM A USER FACILITY IN THE (B)(4) STATED THAT DURING THE SCULPT PHASE OF PHACO, TWO SMALL WHITE PARTICLES WERE OBSERVED IN THE PATIENT'S EYE THAT WERE TOO HARD TO PHACO. THE SURGEON USED CAPSULORHEXIS FORCEPS TO REMOVE THE PARTICLES. ON EXAMINATION THE TIP WRENCH USED DURING THE CASE WAS SHOWN TO BE DAMAGED. THERE WAS NO REPORT OF INJURY OR CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829085 STELLARIS VISION ENHANCEMENT SYSTEM UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5114 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1