BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI SURGICAL SYSTEM

    MDR report key: 9466903 · Received December 13, 2019

    Report

    Report Number
    3010363671-2019-00002
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    October 17, 2019
    Report Date
    December 13, 2019
    Manufacturer
    SIGHT SCIENCES, INC.
    Product Code
    MRH
    UDI-DI
    00858027006310
    PMA / PMN Number
    K173332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO SIGHT SCIENCES, INC. HAS BEEN SUBMITTED. THE COMPANY IS SUBMITTING THIS MDR TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. MFR REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE SURGEON PERFORMED VISCODILATION AND GONIOTOMY WITH THE OMNI SURGICAL SYSTEM AS WELL AS CATARACT SURGERY. SURGERY WAS UNEVENTFUL AND THERE WERE NO INTRAOPERATIVE COMPLICATIONS. AT ONE WEEK POST-SURGERY, THE PATIENT HAD HYPOTONY WITHOUT ANY CLINICAL SIGNS AND THE VISUAL ACUITY WAS UNCHANGED FROM PRE-OP (20/50). THE PATIENT WAS PRESCRIBED STEROIDS TO INCREASE THE IOP. THE PATIENT'S PRESSURE CONTINUED TO BE LOW FOR THE FIRST MONTH POST-SURGERY. AT APPROXIMATELY 6 WEEKS POST-SURGERY ((B)(6) 2019), THE IOP INCREASED TO 10 MMHG BUT THE VISUAL ACUITY HAD DECREASED TO 20/400. AT APPROXIMATELY 2 MONTHS POST-SURGERY ((B)(6) 2019), WITH THE PRESSURE STILL LOW AND THE VISION AT 20/200, THE PATIENT WAS SEEN BY A NEURO-OPHTHALMOLOGIST WHO DIAGNOSED THE PATIENT WITH PAPILLEDEMA DUE TO AN EXTENDED PERIOD OF LOW PERFUSION AS A RESULT OF LOW IOP. THE PATIENT IS UNDER TREATMENT AND OBSERVATION. THE OPTIC NERVE SWELLING HAS REDUCED BUT THE VISION IS STILL 20/200. THE DOCTOR IS UNABLE TO DETERMINE THE PATHOPHYSIOLOGY BEHIND THE PAPILLEDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259100 OMNI SURGICAL SYSTEM VISCOELASTIC INJECTOR MRH SIGHT SCIENCES, INC. 05600 00858027006310

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other