BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7088101 · Received December 6, 2017

    Report

    Report Number
    3005956347-2017-00150
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 10, 2017
    Report Date
    December 6, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THOROUGH MICROSCOPIC INSPECTION REVEALED THERE WAS NO INLAY INSIDE THE LENS CASE AND NO 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. CORNEAL HAZE AND VISION DECREASE 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 CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. TWO WEEKS POSTOPERATIVELY, THE PATIENT PRESENTED WITH MINIMAL CORNEAL HAZE AT WHICH TIME BEST CORRECTED DISTANCE VISION (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/30. THE PATIENT WAS TREATED WITH TOPICAL STEROIDS, BUT WHEN THE STEROIDS WERE DISCONTINUED MILD HAZE RECURRED. THE PATIENT'S BCDVA DECREASED TO 20/80 BEFORE THE INLAY WAS EXPLANTED ON (B)(6) 2017. AT LAST EXAMINATION SEVERAL DAYS POST EXPLANT, BCDVA IMPROVED TO 20/50 AND THE CORNEAL HAZE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866001 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002968 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention