BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLK SINGLE USE SLT LENS (DISPOSABLE)

    MDR report key: 25018652 · Received April 28, 2026

    Report

    Report Number
    MW5187391
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 23, 2026
    Manufacturer
    VOLK OPTICAL INC.
    Product Code
    HKS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FIRST LENS THOUGHT TO HAVE MANUFACTURING DEFECT (PITTING ON FOIL MIRROR), PROCEDURE STOPPED AND LENS SET ASIDE. SECOND LENS SUCTION CUPPED ONTO PATIENT'S EYE, WOULD NOT RELEASE. CAUSED CENTRAL CORNEAL ABRASION IN AFFECTED EYE TRYING TO GET THE LENS OFF. SECOND LENS ALSO NOTED TO HAVE PITTING ON FOIL MIRROR. PATIENT CODE: 1789. DEVICE CODE: 2975, 4001, 1528. REFERENCE REPORT#MW5187390.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230779 VOLK SINGLE USE SLT LENS (DISPOSABLE) PRISM, GONIOSCOPIC HKS VOLK OPTICAL INC. VSLTD CG01061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown