BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 12264002 · Received August 2, 2021

    Report

    Report Number
    2939653-2021-00002
    Event Type
    Injury
    Date Received
    August 2, 2021
    Date of Event
    February 11, 2021
    Report Date
    February 25, 2021
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IRIDEX BECAME AWARE OF A COMPLAINT REPORTING CONJUNCTIVAL BURN ON THE PATIENT'S EYE. IRIDEX MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTING PHYSICIAN WITHOUT RESPONSE. NO ADDITIONAL INFORMATION WAS PROVIDED. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CONCLUSION ON CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER OF THE PROBE WAS NOT PROVIDED WITH THE COMPLAINT. A FIVE YEAR HISTORICAL REVIEW OF COMPLAINT DATA FOR PART NUMBER 15800-1 WAS COMPLETED. BASED ON THE DATA REVIEWED, THIS EVENT DOES NOT APPEAR TO BE A PART OF AN INCREASING TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158163 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 15980-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other