BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7134875 · Received December 20, 2017

    Report

    Report Number
    3005956347-2017-00161
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    October 12, 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. INCREASED VISUAL SYMPTOMS, CORNEAL HAZE, AND INTERFACE DEBRIS ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. (B)(4).

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN A FOREIGN CLINICAL TRIAL AND UNDERWENT UNEVENTFUL IMPLANTATION OF THE INVESTIGATIONAL CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE STUDY INVOLVED THE USE OF MITOMYCIN-C AND LASIK SURGERY WAS PERFORMED CONCURRENT WITH INLAY IMPLANTATION. ON (B)(6) 2017, THE INLAY WAS EXPLANTED IN ORDER TO ADDRESS UNSPECIFIED VISUAL DISTURBANCES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE INVESTIGATOR WHO REPORTS THAT THE PATIENT ALSO HAD CORNEAL HAZE AND INTERFACE DEBRIS. THE PATIENT'S VISUAL DISTURBANCES WERE DESCRIBED AS MILD HALOS AND MODERATE DOUBLE VISION WITH ONSET AT MONTH 15, BUT THE SYMPTOMS DID NOT SIGNIFICANTLY IMPAIR THE PATIENT'S ACTIVITIES OF DAILY LIVING. THE TYPE AND GRADE OF CORNEAL HAZE WAS NOT PROVIDED AND THE RELATIONSHIP BETWEEN HAZE AND THE VISUAL SYMPTOMS IS NOT KNOWN. THE VISUAL DISTURBANCES WERE THOUGHT TO BE CAUSED BY EXTENDED DEBRIS IN THE FLAP INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914640 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS PP6-530-0027-US 002627

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXCIMER LASER FOR LASIK| FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP