BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7068525 · Received November 29, 2017

    Report

    Report Number
    3005956347-2017-00143
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    July 25, 2017
    Report Date
    November 29, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DECREASED VISUAL ACUITY AND INCREASED VISUAL SYMPTOMS ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. ALTHOUGH THE PATIENT EXPERIENCED AN IMPROVEMENT IN UNCORRECTED NEAR VISION, THE INLAY WAS EXPLANTED ON (B)(6) 2017 DUE TO INTOLERABLE VISUAL DISTURBANCES AND DECREASED BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 (PREOPERATIVELY) TO 20/40-2 PRIOR TO EXPLANT. AT LAST EXAMINATION ON (B)(6) 2017, BCDVA IMPROVED TO 20/25 AND THE VISUAL DISTURBANCES HAD ALMOST RESOLVED. THE CAUSE OF THE DECREASED VISION REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848008 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002979 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention