BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7148518 · Received December 27, 2017

    Report

    Report Number
    3005956347-2017-00166
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 27, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS RETURNED TO THE MANUFACTURER, AND THE INVESTIGATION IS UNDERWAY. 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 AND DECREASED VISION ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. (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. THE PATIENT PRESENTED WITH CORNEAL HAZE AND DECREASED VISUAL ACUITY ON (B)(6) 2017. THE CORNEAL HAZE PERSISTED DESPITE COMPLIANT TREATMENT WITH TOPICAL STEROIDS. AT EXAMINATION ON (B)(6) 2017, THE HAZE WORSENED TO GRADE 2-3+ (CENTRAL). THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/30-2 AT ONSET, AND 20/30 IMMEDIATELY PRIOR TO INTERVENTION. THE PATIENT DID NOT RESPOND TO STEROIDS AND ON (B)(6) 2017 THE INLAY WAS REMOVED AND REPLACED WITH A NEW INLAY AND MITOMYCIN-C WAS ADMINISTERED IN THE FLAP INTERFACE. AT LAST EXAMINATION ONE WEEK POST INLAY EXCHANGE, BCDVA WAS 20/50 AND THE CORNEAL HAZE IMPROVED TO MILD. ACCORDING TO THE SURGEON, PRESENCE OF THE INLAY CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927460 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 600-0001 002968 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention