BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6031654 · Received October 14, 2016

    Report

    Report Number
    3005956347-2016-00002
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 22, 2016
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    PMA / PMN Number
    G090149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS RETURNED TO THE MANUFACTURER; HOWEVER, THERE WAS NO INLAY FOUND INSIDE THE CONTAINER WHICH PRECLUDED EVALUATION OF THE DEVICE. THE PATIENT RECEIVED A FLAP DEPTH THAT WAS THINNER THAN RECOMMENDED, WHICH COULD HAVE CONTRIBUTED TO THE DEVELOPMENT OF CORNEAL HAZE. THE DEVICE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING PRECAUTION STATEMENT: "DO NOT IMPLANT THE RAINDROP NEAR VISION INLAY UNDER A FEMTOSECOND LASER FLAP SHALLOWER THAN 30% OF THE CENTRAL CORNEAL THICKNESS." (B)(4).

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS RECEIVED IN A CONDITION THAT PRECLUDED ANALYSIS, THEREFORE NO TESTING WILL BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) FOR THIS MANUFACTURING LOT WAS REVIEWED AND THE DEVICE MET ALL RELEASE CRITERIA AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. RECURRENT CORNEAL HAZE, INLAY REMOVAL, AND LOSS OF CONTRAST SENSITIVITY IN LOW LIGHT CONDITIONS ARE LISTED IN THE DEVICE LABELING AS KNOWN COMPLICATIONS OF CORNEAL INLAY SURGERY. COMPLAINT REFERENCE# (B)(4). DATE EMDR SUBMITTED:10/14/2016.

    Description of Event or Problem · 1

    THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2016. AT THE ONE-WEEK POSTOPERATIVE VISIT THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/20. THE CORNEAL HAZE WAS DESCRIBED AS CENTRAL AND PERIPHERAL CORNEAL HAZE. IN ADDITION, RING INFLAMMATION/HAZE WAS OBSERVED ON THE CORNEAL INLAY. THE VISUAL DISTURBANCES DID NOT SIGNIFICANTLY IMPACT THE PATIENT'S ACTIVITIES OF DAILY LIVING. THE HAZE AND VISUAL DISTURBANCES HAVE BOTH RESOLVED AND THE PATIENT'S MOST RECENT BCDVA WAS 20/25. THE CORNEAL FLAP WAS THINNER THAN RECOMMENDED (175 MICRONS WITH A PREOPERATIVE PACHYMETRY OF 546 MICRONS) WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN THE CLINICAL TRIAL FOR IDE #(B)(4) AND UNDERWENT SURGERY ON (B)(6) 2013 WITH IMPLANTATION OF THE INVESTIGATIONAL CORNEAL INLAY. ON (B)(6) 2016, THE STUDY SITE REPORTED EXPLANTING THE INLAY DUE TO RECURRENT HAZE AND NIGHT VISION DISTURBANCES IN THE OPERATIVE EYE. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681805 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS PP6-530-0027-US 002455

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP.