BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION SURGICAL INSTRUMENT

    MDR report key: 17804982 · Received September 23, 2023

    Report

    Report Number
    3010363671-2023-00023
    Event Type
    Injury
    Date Received
    September 23, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 22, 2023
    Manufacturer
    SIGHT SCIENCES INC
    Product Code
    HMZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN WHO PERFORMED A SION PROCEDURE REPORTED THAT THE PATIENT WAS PRESENTED WITH HYPOTONY MACULOPATHY. IT WAS NOTED THAT THE IOP WAS 9MMHG AND FOLDS WERE OBSERVED. AFTER A FOLLOW UP WITH THE PATIENT, THE PHYSICIAN COMMENTED THAT THE PATIENT HAD REBOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561730 SION SURGICAL INSTRUMENT SION SURGICAL INSTRUMENT HMZ SIGHT SCIENCES INC 1-107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other