BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6881493 · Received September 20, 2017

    Report

    Report Number
    3005956347-2017-00109
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 20, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 WAS RECEIVED IN AN EMPTY/DRY CONTACT LENS CASE (NOT STORED IN SOLUTION) AND EXAMINATION SHOWED PARTICLES ON THE INLAY SURFACE. THE PRESENCE OF THE OBSERVED PARTICULATES IS LIKELY THE RESULT OF CONTAMINATION DURING REMOVAL FROM THE EYE AND STORAGE/TRANSPORT, AS EVIDENCED BY THE DRY LENS CASE IN WHICH IT WAS STORED POST EXPLANT AND THE FACT THAT THE INITIAL REPORTER NEVER REPORTED ANY PROBLEM WITH THE INLAY SURFACE OR APPEARANCE. 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 POSITION IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. 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) 2016. THE INLAY WAS EXPLANTED ON (B)(6) 2017 DUE TO INLAY DECENTRATION 1 MM SUPERIORLY. THE DECENTRATION DID NOT RESULT IN ANY ADVERSE IMPACT ON VISION. THE PATIENT'S PROGNOSIS POST EXPLANT WAS REPORTED AS GOOD AND STABLE. THE SURGEON BELIEVES THE DECENTRATION WAS RELATED TO ENDOTHELIAL DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660865 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002999 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR