BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 12264051 · Received August 2, 2021

    Report

    Report Number
    2939653-2021-00005
    Event Type
    Injury
    Date Received
    August 2, 2021
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    UDI-DI
    00813125016555
    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 AN ADVERSE EVENT FROM LITERATURE REVIEW. A STUDY WAS CONDUCTED TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY PROFILE OF MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION (MP-CPC) IN PATIENTS WITH REFRACTORY GLAUCOMA. THE STUDY NOTED 2 PATIENTS WITH PHTHISIS,7 PATIENTS WITH HYPOTONY AND 13 PATIENT WITH LOSS OF VISUAL ACUITY AFTER MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION. THE STUDY CONCLUDED THAT MP-CPC IS AN EFFECTIVE TREATMENT FOR PATIENTS WITH REFRACTORY GLAUCOMA AND THAT SHORTER TREATMENT TIMES WITH MORE FREQUENT REPEAT TREATMENTS MAY BE CONSIDERED GIVEN THE INCIDENCE OF SIGNIFICANT VISION LOSS IN THIS STUDY. NO PATIENT FOLLOWUP INFORMATION HAS BEEN PROVIDED IN THE ARTICLE. LITERATURE REFERENCE: "CLINICAL EFFICACY AND SAFETY PROFILE OF MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION IN REFRACTORY GLAUCOMA - PUBMED." PUBMED, HTTPS://PUBMED.NCBI.NLM.NIH.GOV/29521718/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161006 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 00813125016555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other