BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6974753 · Received October 24, 2017

    Report

    Report Number
    3005956347-2017-00129
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 24, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS RETURNED TO THE MANUFACTURER AND SUBJECTED TO VISUAL MICROSCOPIC INSPECTION AND DIMENSIONAL ANALYSIS. THE EDGE THICKNESS AND DIAMETER WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE INLAY HAD A VERY SMALL CUT NEAR THE EDGE AND SOME PARTICLES WERE OBSERVED ON THE SURFACE, BUT THESE FINDINGS ARE CONSISTENT WITH FINDINGS FOR CORNEAL INLAYS THAT HAVE BEEN EXPLANTED SINCE SURGICAL INSTRUMENTS ARE REQUIRED TO REMOVE THE DEVICE FROM THE EYE AND PLACE IT IN A HYDRATED STORAGE CONTAINER FOR TRANSPORT. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. INLAY SHIFTS IN POSITON AND DECREASED VISION ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. COMPLAINT REFERENCE #: (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) 2017. THE INLAY DECENTERED 3 MM INFERIORLY AND RESULTED IN A DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 PREOPERATIVELY TO 20/70-1. THE INLAY WAS EXPLANTED ON (B)(6) 2017. AT LAST EXAMINATION ONE MONTH POST EXPLANT BCDVA IMPROVED TO 20/20-1 AND THE CORNEA WAS HEALING IDEALLY. THE SURGEON ATTRIBUTED THE INLAY DECENTRATION TO A STEROID-INDUCED IOP SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753115 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 003132 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention