BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 11661056 · Received April 13, 2021

    Report

    Report Number
    2939653-2021-00012
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 6, 2021
    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 PATIENT REPORTING PAIN IN THE EYE FOLLOWING A PROCEDURE USING CYCLO-G6 AND MICROPULSE P3 DELIVERY DEVICE. DURING FOLLOW-UP PATIENT DEMONSTRATED VISION LOSS GREATER THAN TWO LINES. IT IS UNKNOWN IF THE VISION LOSS IS TRANSIENT. THE IOP WAS SUCCESSFULLY REDUCED; HOWEVER EDEMA OF THE CORNEAL EPITHELIA AND HYPERAMIA OF THE CONJUNCTIVA WERE ALSO OBSERVED. A VITRECTOMY WAS PERFORMED AND IT WAS CONFIRMED THAT THE EDEMA RESOLVED. THE LASER TREATMENT PARAMETERS WERE REPORTED BY THE DOCTOR AND WERE CONFIRMED TO BE CONSISTENT WITH ESTABLISHED PROTOCOLS. IT WAS STATED THAT THE PATIENT EXPERIENCED UNDERLYING CONDITIONS AND IT IS UNKNOWN THESE CONDITIONS WERE A CONTRIBUTING FACTOR FOR THE POSTOPERATIVE COMPLICATIONS. A SPECIFIC ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. ENGINEERING ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558255 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other