BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3

    MDR report key: 14277759 · Received May 4, 2022

    Report

    Report Number
    2939653-2022-00010
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    March 21, 2022
    Report Date
    October 4, 2023
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    UDI-DI
    00813125015220
    PMA / PMN Number
    K143154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. IRIDEX MADE ATTEMPTS TO FOLLOW UP AND GATHER ADDITIONAL INFORMATION BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE MANUFACTURING DEVICE HISTORY RECORDS WERE REVIEWED, AND NO ANOMALIES OR ISSUES WERE IDENTIFIED. THE RESULTS OF POST MARKET DATA REVIEW SUGGEST THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NUMBER OF EVENTS REPORTED EVALUATED AGAINST THE NUMBER OF CASES PERFORMED.

    Description of Event or Problem · 0

    PART A IS NOT FILLED OUT AS PATIENT IDENTIFIER DETAILS WERE NOT PROVIDE TO IRIDEX. THIS REPORT HAS BEEN CREATED TO MAKE CORRECTIONS TO THE PREVIOUS REPORT. THE CHANGES INCLUDE: 1) REPORT C: IS THIS A COMBINATION PRODUCT - NO 2) REPORT D: UPDATES TO SECTION D8, D9. DEVICE DETAILS UPDATED FROM CYCLO G6 TO MICROPULSE P3 IN SECTION D1. 3) PART H: UPDATE TO INCLUDE THAT THIS A CORRECTION REPORT 4) PART D: UPDATE THE LOT NUMBER INFORMATION. THE LOT NUMBER WAS FILLED OUT IN THE SECTION FOR SERIAL NUMBER. UPDATED THIS SECTION WITH THE UDI NUMBER. 5) PART E: UPDATES TO THE INITIAL REPORTER SECTION WITH INFORMATION REGARDING THE COMPLAINANT 6) PART H4: UPDATES TO DATE OF MANUFACTURE. THIS INFORMATION WAS NOT SUBMITTED PREVIOUSLY THE FOLLOWING TEXT WERE PROVIDED IN THE INITIAL REPORT: IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING CONJUNCTIVAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE AND CYCLO G6 LASER SYSTEM. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. ENGINEERING FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CLINIC OR TREATING PHYSICIAN. IRIDEX MADE ATTEMPTS TO FOLLOW UP AND GATHER ADDITIONAL INFORMATION BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE MANUFACTURING DEVICE HISTORY RECORDS WERE REVIEWED, AND NO ANOMALIES OR ISSUES WERE IDENTIFIED. THE RESULTS OF POST MARKET DATA REVIEW SUGGEST THAT THIS FAILURE MODE IS NOT OCCURRING WITH GREATER SEVERITY OR FREQUENCY BASED ON THE NUMBER OF EVENTS REPORTED EVALUATED AGAINST THE NUMBER OF CASES PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218356 MICROPULSE P3 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 15522 870028 00813125015220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other