BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6963471 · Received October 19, 2017

    Report

    Report Number
    3005956347-2017-00126
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    May 22, 2017
    Report Date
    December 8, 2017
    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 EXPLANTED INLAY WAS RETURNED TO THE MANUFACTURER AND SUBJECTED TO VISUAL MICROSCOPIC INSPECTION AND DIMENSIONAL ANALYSIS. THE EDGE THICKNESS AND DIAMETER WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. CUTS AND PARTICLES WERE OBSERVED ON THE DEVICE, BUT THESE FINDINGS ARE CONSISTENT WITH FINDINGS FOR CORNEAL INLAYS THAT HAVE BEEN EXPLANTED SINCE SURGICAL INSTRUMENTS ARE REQUIRED TO REMOVE THE DEVICE FROM THE EYE AND PLACE IT IN A HYDRATED STORAGE CONTAINER FOR TRANSPORT. THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE MANUFACTURING LOT FOR THIS DEVICE WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. COMPLAINT REFERENCE NUMBER: (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 RIGHT EYE ON (B)(6) 2016. THE STUDY INVOLVED THE USE OF A CORNEAL POCKET FOR IMPLANTATION OF THE INLAY. SIX MONTHS POSTOPERATIVELY THE PATIENT PRESENTED WITH FAINT CENTRAL CORNEAL HAZE THAT RECURRED 9 MONTHS POSTOPERATIVELY AND AGAIN 12 MONTHS POSTOP. IMMEDIATELY PRIOR TO EXPLANT ON (B)(6) 2017, THE CENTRAL CORNEAL HAZE WAS GRADED AS FAINT. THE SURGEON BELIEVES THAT EXTENDED DEBRIS IN THE CORNEAL POCKET CONTRIBUTED TO THE DEVELOPMENT OF HAZE. THE HAZE DID NOT RESULT IN A CLINICALLY SIGNIFICANT 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

    RVO RECEIVED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT HAS BEEN DEEMED LOST TO FOLLOW-UP AFTER SERVERAL ATTEMPTS TO BRING THE PATIENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742759 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 600-0032 002627

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention