BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7115282 · Received December 13, 2017

    Report

    Report Number
    3005956347-2017-00155
    Event Type
    Injury
    Date Received
    December 13, 2017
    Report Date
    December 13, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INLAY REMAINS IMPLANTED, THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT FOR THIS DEVICE WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. THE SOURCE OF THE DEBRIS IS UNKNOWN. DECREASED VISION IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    TWO MONTHS POST UNEVENTFUL INLAY EXCHANGE, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) REMAINS 20/40. IN THE EARLY POSTOPERATIVE PERIOD THE PATIENT HAD CORNEAL EDEMA AND INTERFACE DEBRIS WITH FLAP STRIAE PERIPHERALLY, BUT THESE EVENTS WERE SELF-RESOLVING AND WERE NOT CONSIDERED SERIOUS. THE INLAY REMAINS IMPLANTED AND THE SURGEON STATES THE PATIENT IS IMPROVING. THE REASON FOR THE DECREASED VISION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893538 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 003109 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention