BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6963664 · Received October 19, 2017

    Report

    Report Number
    3005956347-2017-00123
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    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. A SMALL PORTION NEAR THE INLAY EDGE WAS TORN OFF AND SOME PARTICLES WERE PRESENT ON THE 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. 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. COMPLAINT REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    DECREASED VISUAL ACUITY IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. TWO MONTHS POSTOPERATIVELY THE PATIENT PRESENTED WITH CORNEAL HAZE THAT DID NOT RESPOND TO TREATMENT WITH DUREZOL AND THE INLAY WAS EXPLANTED ON (B)(6) 2017. THE TYPE OF HAZE AND IMPACT ON VISION IS NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THERE WERE NO COMPLICATIONS DURING SURGERY TO IMPLANT THE INLAY, AND THE PATIENT HAD NO PRE-EXISTING CONDITIONS. SIX WEEKS POSTOPERATIVELY THE PATIENT PRESENTED WITH GRADE 2+ CORNEAL HAZE ON THE EDGE OF THE INLAY. THE CORNEAL HAZE WAS ASSOCIATED WITH A DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 (PREOPERATIVELY) TO 20/40 (AT FIRST ONSET), IMPROVING TO 20/25 IMMEDIATELY PRIOR TO INLAY EXPLANTATION. POST INLAY EXPLANT, THE CORNEAL HAZE HAS RESOLVED WITH 20/25 BCDVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742769 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 003045 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention