BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6915429 · Received October 5, 2017

    Report

    Report Number
    3005956347-2017-00114
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 1, 2017
    Report Date
    December 5, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. A CUT AND SOME PARTICLES WERE OBSERVED ON THE INLAY SURFACE, 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. IT SHOULD BE NOTED THAT THE DEVICE WAS NOT PROPERLY STORED DURING TRANSPORT AND IT WAS RECEIVED IN A NON-HYDRATED STATE. IN ADDITION, THE INITIAL REPORTER NEVER REPORTED ANY PROBLEM WITH THE INLAY (NO CUTS OR PARTICLES REPORTED). 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 AND DECREASED VISION ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. APPROXIMATELY TWO (2) MONTHS POST EXPLANTATION OF THE INLAY, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) HAS RETURNED TO BASELINE AND BLURRY VISION HAS RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. APPROXIMATELY 5 MONTHS POSTOPERATIVELY, THE PATIENT PRESENTED WITH 1+ PERIPHERAL EDGE HAZE IN THE OPERATIVE EYE. AT THIS TIME THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) HAD DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/50 AT ONSET, IMPROVING TO 20/30 IMMEDIATELY PRIOR TO EXPLANT. THE CORNEAL HAZE PERSISTED THROUGHOUT THE POSTOPERATIVE PERIOD AND THE INLAY WAS EXPLANTED ON (B)(6) 2017. AT LAST EXAMINATION ONE WEEK POST EXPLANT, THE BCDVA REMAINED AT 20/30. THE SURGEON ATTRIBUTED THE EVENT TO A FOREIGN BODY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695703 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002990 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention