BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7148434 · Received December 27, 2017

    Report

    Report Number
    3005956347-2017-00165
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 27, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE EDGE THICKNESS AND DIAMETER WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE INLAY WAS RECEIVED IN A DEHYDRATED STATE AND TORN IN 2 PIECES WITH A DARK RESIDUE OBSERVED ON THE SURFACE. THE DARK RESIDUE CAME OFF ONCE THE INLAY WAS REHYDRATED. 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 STORAGE CONTAINER FOR TRANSPORT. IT SHOULD BE NOTED THAT THE DEVICE WAS NOT PROPERLY STORED DURING TRANSPORT AND IT WAS RECEIVED IN A NON-HYDRATED STATE. 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 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) 2017. T HE INLAY WAS EXPLANTED ON (B)(6) 2017 IN ORDER TO ADDRESS CORNEAL HAZE. THE SURGEON REPORTS THE CORNEAL HAZE IS RESOLVING. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927819 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002999 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention