BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPULSE P3

    MDR report key: 14528395 · Received May 27, 2022

    Report

    Report Number
    2939653-2022-00014
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 24, 2024
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    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

    Additional Manufacturer Narrative · 0

    NOTE: PATIENT INFORMATION WAS NOT PROVIDED, THEREFORE PART A IS NOT FILLED OUT.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. THE EYE WAS WIPED WITH BETADINE AS PER THE NURSE, AND IT COULD NOT BE CONFIRMED IF ANY RESIDUAL BETADINE WAS PRESENT IN THE EYE PRIOR TO TREATMENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. THE MICROPULSE P3 IFU HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. 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.

    Description of Event or Problem · 0

    IRIDEX BECAME AWARE OF A PATIENT EXPERIENCING SCLERAL BURN DURING TREATMENT WITH A MICROPULSE P3 PROBE. BASED ON THE INFORMATION PROVIDED, IT APPEARS THE TREATMENT WAS PERFORMED WITHIN SPECIFICATIONS. THE EYE WAS WIPED WITH BETADINE AS PER THE NURSE, AND IT COULD NOT BE CONFIRMED IF ANY RESIDUAL BETADINE WAS PRESENT IN THE EYE PRIOR TO TREATMENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE ISSUE IS SUSPECTED TO BE CONTAMINATION (BETADINE) ON THE PROBE TIP WHEN THE LASER WAS ACTIVATED OR LASER ACTIVATION WHEN THE PROBE IS OVER PIGMENTED CONJUNCTIVAL TISSUE. THE MICROPULSE P3 IFU HAS CLEAR INSTRUCTIONS TO EXAMINE THE PROBE TIP BEFORE TREATMENT AND TO AVOID AREAS OF PERILIMBAL PIGMENTATION. PER THE IFU 'EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227077 MICROPULSE P3 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 15522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other