BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6949459 · Received October 13, 2017

    Report

    Report Number
    3005956347-2017-00120
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 14, 2017
    Report Date
    December 14, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (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 AND THE INLAY WAS CLEAR AND DID NOT HAVE A CLOUDY APPEARANCE. SURFACE DAMAGE (TEARS AND 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 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

    PATIENT FOLLOW-UP WAS REQUESTED AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. AT LAST EXAMINATION ON (B)(6) 2017 THE PATIENT'S DISTANCE VISION HAS IMPROVED. THE BEST CORRECTED DISTANCE VISION (BCDVA) WAS NOT MEASURED BUT THE UNCORRECTED DISTANCE VISION (UCDVA) WAS 20/30.

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. INLAY IMPLANTATION WAS UNEVENTFUL AND LASIK SURGERY WAS PERFORMED IN THE OPERATIVE EYE CONCURRENT WITH INLAY IMPLANTATION. THE SURGEON CLARIFIED THAT THE PRIMARY REASON FOR INLAY REMOVAL WAS TO PERFORM LASIK ENHANCEMENT, HOWEVER, PRIOR TO EXPLANT THE PATIENT HAD 1+ CORNEAL HAZE AND BCDVA HAD DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/30- AT ONSET, IMPROVING TO 20/25- IMMEDIATELY PRIOR TO EXPLANTATION. AT LAST EXAMINATION ON (B)(6) 2017 THE CORNEAL HAZE RESOLVED, HOWEVER BCDVA DECREASED TO 20/60. THE SURGEON REPORTS THAT EARLY DISCONTINUATION OF DUREZOL (NON-COMPLIANCE) MAY HAVE BEEN A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. EIGHT MONTHS POSTOPERATIVELY THE INLAY WAS EXPLANTED TO ADDRESS CORNEAL HAZE AND INLAY FIBROSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO UNDERSTAND THE TYPE OF HAZE AND IMPACT ON VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726757 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002999 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R