BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 11660944 · Received April 13, 2021

    Report

    Report Number
    2939653-2021-00011
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 31, 2021
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    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 A CONJUNCTIVAL HEMORRHAGE DURING TREATMENT. THE PATIENT ALSO REPORTED EXPERIENCING PAIN FOLLOWING A PROCEDURE USING MICROPULSE P3 PROBE. THE FIBER TIP WAS REPORTED TO BE PROTRUDING BY 2-3 MM DURING THE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ENGINEERING FAILURE ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE AND THE RESULTS CONFIRMED THIS OBSERVATION. SUPPLIER NOTIFICATION WAS COMPLETED AND THE SUPPLIER PERFORMED A BATCH RECORD REVIEW. A SPECIFIC CAUSE WAS NOT DETERMINED. IT IS POSSIBLE THAT THE FIBER BECAME LOOSE EITHER DURING TRANSIT OR DURING TREATMENT. A FIVE YEAR HISTORICAL REVIEW OF COMPLAINT DATA FOR MICROPULSE P3 WAS COMPLETED. THE DEVICE HAZARD ANALYSIS WAS ALSO REVIEWED AND THERE IS NO IMPACT TO THE RISK EVALUATION ASSOCIATED WITH THIS INCIDENT. BASED ON THE DATA REVIEWED, THIS EVENT DOES NOT APPEAR TO BE OCCURING WITH A GREATER FREQUENCY OR SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558797 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 900029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other