BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6949106 · Received October 13, 2017

    Report

    Report Number
    3005956347-2017-00119
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 13, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, MICROSCOPIC VISUAL INSPECTION REVEALED THERE WAS NO INLAY INSIDE THE CONTACT LENS CASE AND NO FURTHER ANALYSIS COULD BE PERFORMED. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. DECREASED VISION AND GLARE 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 WAS EXPLANTED 2 MONTHS POSTOPERATIVELY DUE TO INTOLERABLE GLARE AND DECREASED BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/15 (PREOPERATIVELY) TO 20/25. THE SURGEON REPORTED THAT THE PATIENT HAD A POOR TOLERANCE OF THE SMALL AMOUNT OF ANISOMETROPIA INDUCED BY THE INLAY. AT LAST EXAMINATION POST-EXPLANT ON (B)(6) 2017, THE PATIENT'S PROGNOSIS WAS GOOD WITH BCDVA IMPROVING TO 20/20 AND THE GLARE RESOLVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727213 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 003071 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention