BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 12264015 · Received August 2, 2021

    Report

    Report Number
    2939653-2021-00004
    Event Type
    Injury
    Date Received
    August 2, 2021
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    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 48-PATIENT STUDY WAS CONDUCTED TO COMPARE THE EFFICACY AND SAFETY OF TRANSSCLERAL CYCLOPHOTOCOAGULATION TREATMENT USING MICROPULSE MODE VERSUS CONTINUOUS WAVE MODE. THE ARTICLE DISCUSSES ONE CASE OF PHTHISIS BULBI AFTER A TRANSCLERAL PHOTOCOAGULATION PROCEDURE WAS PERFORMED IN CONTINUOUS WAVE MODE. OBSERVATIONS OF PROLONGED HYPOTONY WERE NOTED DURING SIX MONTH FOLLOW-UP FOR SOME PATIENTS WHO WERE TREATED IN CONTINUOUS WAVE MODE. THE NUMBER OF PATIENTS AFFECTED IS NOT MENTIONED. THE RESULTS OF THE STUDY CONCLUDES THAT BOTH TREATMENT MODES ARE EFFECTIVE IN REDUCING INTRAOCULAR PRESSURE. THE JOURNAL ARTICLE ALSO CONCLUDED THAT MICROPULSE MODE PROVIDED A MORE CONSISTENT AND PREDICTABLE EFFECT IN LOWERING INTRAOCULAR PRESSURE WITH MINIMAL OCULAR COMPLICATIONS. LITERATURE REFERENCE : "MICROPULSE VERSUS CONTINUOUS WAVE TRANSSCLERAL DIODE CYCLOPHOTOCOAGULATION IN REFRACTORY GLAUCOMA: A RANDOMIZED EXPLORATORY STUDY - PUBMED." PUBMED, HTTPS://PUBMED.NCBI.NLM.NIH.GOV/24811050/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161027 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other