BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7119689 · Received December 14, 2017

    Report

    Report Number
    3005956347-2017-00159
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    October 20, 2017
    Report Date
    December 14, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS DISCARDED BY THE FACILITY AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS WERE NOT AVAILABLE. 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) 2016. IT SHOULD BE NOTED THAT LASIK SURGERY WAS PERFORMED ON THIS EYE CONCURRENT WITH INLAY IMPLANTATION. THE INLAY WAS EXPLANTED ON (B)(6) 2017 IN ORDER TO ADDRESS GRADE 1+ RECURRENT CENTRAL CORNEAL HAZE (FIRST ONSET WAS AT MONTH 3). AT LAST EXAMINATION POST EXPLANT, TRACE CORNEAL EDGE HAZE WAS OBSERVED AND THE PATIENT'S BEST CORRECTED DISTANCE VISION (BCDVA) WAS 20/30-1. THE SURGEON SUSPECTS THE HAZE WAS CAUSED BY A REACTION TO THE INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895623 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention