BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6978379 · Received October 25, 2017

    Report

    Report Number
    3005956347-2017-00130
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS DISCARDED BY THE FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. CORNEAL HAZE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (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 PATIENT HAD CHRONIC INFLAMMATION STARTING 2 WEEKS POSTOPERATIVELY THAT PERSISTED THROUGHOUT THE POSTOPERATIVE PERIOD. THE INFLAMMATION WAS CHARACTERIZED AS GRADE 3+ CENTRAL CORNEAL HAZE, HOWEVER THERE WAS NO REPORT OF A SIGNIFICANT DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) OR DISABLING VISUAL DISTURBANCES. THE PATIENT WAS A STEROID RESPONDER WHICH MADE TREATMENT OF HAZE NEARLY IMPOSSIBLE AND THE INLAY WAS EXPLANTED ON (B)(6) 2017. AT LAST EXAMINATION ONE WEEK POST EXPLANT, THE HAZE HAD RESOLVED ALMOST COMPLETELY AND BCDVA WAS 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757958 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002999 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention