BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7022912 · Received November 10, 2017

    Report

    Report Number
    3005956347-2017-00139
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 10, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    PMA / PMN Number
    G090149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. CORNEAL HAZE AND DECREASED VISION ARE IS LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE INVESTIGATIONAL RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2012. INLAY EXPLANTATION WAS SCHEDULED 5 YEARS POSTOPERATIVELY DUE TO RECURRENT CORNEAL HAZE WITH INITIAL ONSET AT MONTH 18 AND RECURRENCES AT MONTHS 30, 36, AND 60. IMMEDIATELY PRIOR TO EXPLANT THE CORNEAL HAZE WAS CHARACTERIZED AS GRADE 1 CENTRAL HAZE. THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 PREOPERATIVELY TO 20/32 IMMEDIATELY PRIOR TO EXPLANT. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798868 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. PP6-530-0027-US 002345

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention