BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 GA POSTERIOR WIDE-FIELD ELITE PACK

    MDR report key: 9433041 · Received December 6, 2019

    Report

    Report Number
    0001920664-2019-00245
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 11, 2019
    Manufacturer
    BAUSCH + LOMB, INC
    Product Code
    HQC
    PMA / PMN Number
    K170052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G5 -510K TO K170052; D1 TO 25 GA POSTERIOR WIDE-FIELD ELITE PACK. ADDITIONAL INFO: THE DEVICE HAS BEEN DISCARDED BY THE USER FACILITY. NO SERIAL NUMBER IS AVAILABLE, THEREFORE NO DHR REVIEW COULD BE PERFORMED. NO ROOT CAUSE COULD BE DETERMINED SINCE NO DEVICE WAS RETURNED. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION WAS DEEMED NECESSARY. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT RETAINED, AND THEREFORE CANNOT BE RETURNED FOR EVALUATION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INVESTIGATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS THEY HAVE BEEN HAVING PROBLEMS WITH THE CUTTER OVER THE LAST MONTH. THE CUTTER DOES NOT CUT CORRECTLY. IT IS REPORTED THAT THE CUTTER STIRS THE VITREOUS BUT DOES NOT CUT IT UNLESS IT HAS BEEN REMOVED AND PLACED BACK IN THE EYE. THEN, IT EITHER WORKS OR THEY HAVE TO SWITCH CUTTERS. SITE DID NOT SPECIFY HOW MANY TIMES THIS OCCURRED, BUT SAID IT OCCURRED FREQUENTLY IN THE LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224138 25 GA POSTERIOR WIDE-FIELD ELITE PACK UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB, INC SE5425WV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS VISION ENHANCEMENT SYSTEM