BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6963035 · Received October 19, 2017

    Report

    Report Number
    3005956347-2017-00125
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 15, 2017
    Report Date
    January 10, 2018
    Manufacturer
    REVISION OPTICS, INC.
    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 SITE IS BEING CONTACTED TO CLARIFY WHETHER THE DEVICE IS AVAILABLE FOR EVALUATION. THE REVIEW OF THE DEVICE HISTORY RECORD IS UNDERWAY AND WILL BE REPORTED IN A FOLLOW-UP REPORT. CORNEAL HAZE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN A FOREIGN CLINICAL TRIAL AND UNDERWENT UNEVENTFUL IMPLANTATION OF THE INVESTIGATIONAL RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE STUDY INVOLVED THE USE OF A CORNEAL POCKET FOR IMPLANTATION OF THE INLAY. ONE YEAR POSTOPERATIVELY THE PATIENT PRESENTED WITH FAINT CENTRAL CORNEAL HAZE AND THE INLAY WAS EXPLANTED ON (B)(6) 2017. THE SURGEON BELIEVES THAT EXTENDED DEBRIS IN THE CORNEAL POCKET CONTRIBUTED TO THE DEVELOPMENT OF HAZE. THE HAZE DID NOT RESULT IN A DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA). THE PATIENT IS SCHEDULED FOR EXAMINATION 1-MONTH AND 3-MONTHS POST INLAY REMOVAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM STUDY PERSONNEL, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT WAS EXAMINED ONE MONTH POST EXPLANT ON (B)(6) 2017. AT THIS VISIT THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) REMAINED STABLE AT 20/16 WITH PERSISTENT TRACE (0.5) CENTRAL CORNEAL HAZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742206 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 600-0032 002627

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention