BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6979196 · Received October 26, 2017

    Report

    Report Number
    3005956347-2017-00131
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 26, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS RETURNED TO THE MANUFACTURER AND SUBJECTED TO VISUAL MICROSCOPIC INSPECTION AND DIMENSIONAL ANALYSIS. VISUAL INSPECTION REVEALED THAT THE INLAY DID NOT HAVE A CLOUDY APPEARANCE. DIMENSIONAL ANALYSIS (MEASUREMENT OF EDGE THICKNESS AND DIAMETER) WAS UNABLE TO BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE INLAY, WHICH WAS TORN INTO 4 SEPARATE PIECES; THE PIECES WERE OBSERVED WITH CUTS AND PARTICLES ON THE SURFACE. SINCE THERE WAS NO REPORT OF INLAY DAMAGE, THE DAMAGE IS PRESUMED TO HAVE OCCURRED DURING THE EXPLANT PROCEDURE, WHERE DAMAGE CAN OCCUR FROM THE SURGICAL INSTRUMENTS USED TO REMOVE THE DEVICE FROM THE EYE AND PLACE IT IN A HYDRATED STORAGE CONTAINER FOR TRANSPORT. 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 IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED 10 MONTHS POSTOPERATIVELY DUE TO CORNEAL HAZE ON AND AROUND THE INLAY THAT PERSISTED FROM 3 MONTHS POSTOPERATIVELY UNTIL EXPLANT. THERE WAS NO SIGNIFICANT DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY, HOWEVER, THE PATIENT EXPERIENCED SIGNIFICANT GLARE SYMPTOMS AT NIGHT. CENTRAL CORNEAL HAZE WAS PRESENT AT THE LAST EXAMINATION ONE DAY POST EXPLANT AND BCDVA WAS 20/25. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759826 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002984 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention