BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCO360 VISCOSURGICAL SYSTEM

    MDR report key: 6343187 · Received February 20, 2017

    Report

    Report Number
    3010363671-2017-00001
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 21, 2017
    Report Date
    January 25, 2017
    Manufacturer
    SIGHT SCIENCES, INC.
    Product Code
    MRH
    UDI-DI
    00858027006013
    PMA / PMN Number
    K143205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE DEVICE WAS DISCARDED BY THE FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS (MANUFACTURING AND STERILIZATION) WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT HAD UNEVENTFUL CATARACT SURGERY FOLLOWED BY VASODILATION OF SCHLEMM'S CANAL IN THE LEFT EYE. TWO DAYS POSTOPERATIVELY THE PATIENT WAS DIAGNOSED WITH TASS WITH ASSOCIATED ANTERIOR CHAMBER INFLAMMATION, HYPOPYON, INCREASED WHITE BLOOD CELLS IN THE ANTERIOR CHAMBER, AND DECREASED VISUAL ACUITY. PREOPERATIVELY, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40; AT ONSET, BCVA DECREASED TO 20/100 AND IOP WAS MEASURED AT 14 MMHG. THE PATIENT WAS TREATED WITH TOPICAL STEROIDS, TOPICAL ANTIBIOTICS, AND AN INTRAVITREAL INJECTION. THE EYE WAS CULTURED AND RESULTS WERE NEGATIVE FOR BACTERIA AND FUNGUS. ON FEBRUARY 16, 2017, THE DOCTOR REPORTED THAT THE PATIENT WAS FULLY RECOVERED WITH AN UNCORRECTED VISUAL ACUITY OF 20/50 AND A PINHOLE ACUITY OF 20/30. THERE HAVE BEEN NO OTHER REPORTS OF TASS AT THIS SURGICAL FACILITY AND THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125382 VISCO360 VISCOSURGICAL SYSTEM VISCOELASTIC INJECTOR MRH SIGHT SCIENCES, INC. 03916 1005195 00858027006013

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention CATARACT SURGERY| HEALON GV USED IN VISCO360 DEVICE