BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7136654 · Received December 20, 2017

    Report

    Report Number
    3005956347-2017-00163
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 20, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED CORNEAL INLAY HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME. THE SITE IS BEING CONTACTED TO DETERMINE WHETHER IT IS STILL AVAILABLE FOR ANALYSIS. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT FOR THIS DEVICE WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. CORNEAL HAZE AND CORNEAL SWELLING ARE LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN A FOREIGN CLINICAL TRIAL AND UNDERWENT IMPLANTATION OF THE INVESTIGATIONAL RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2009. THE INLAY WAS EXPLANTED 8+ YEARS POSTOPERATIVELY TO ADDRESS PERSISTENT CENTRAL CORNEAL HAZE WITH FIRST KNOWN ONSET AT MONTH 82. THE HAZE WAS GRADED AS 0.5 IMMEDIATELY PRIOR TO EXPLANT. OCT PERFORMED AT MONTH 99 SHOWED MILD CORNEAL EDEMA AND HAZE WITH 1.0 D FLATTENING AND A 0.625 D HYPEROPIC SHIFT. THE PATIENT'S BCDVA AT MONTH 99 WAS 20/20. IT SHOULD BE NOTED THAT THE SUBJECT HAD NOT BEEN EXAMINED SINCE 2009. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913042 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS PP3-530-0027-US 0020898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention