BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6977913 · Received October 25, 2017

    Report

    Report Number
    3005956347-2017-00132
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 25, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IDENTIFIER HAS BEEN REQUESTED. CORNEAL HAZE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. COMPLAINT REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. THE INLAY WAS EXPLANTED 9 MONTHS POSTOPERATIVELY DUE TO CORNEAL HAZE THAT DID NOT RESPOND TO TREATMENT WITH TOPICAL STEROIDS. THE TYPE OF HAZE AND IMPACT ON VISION IS NOT KNOWN AT THIS TIME. IT SHOULD BE NOTED THAT THE PATIENT UNDERWENT PRK IN THE OPERATIVE EYE 11 WEEKS PRIOR TO EXPLANT, WHICH MAY HAVE BEEN CONTRIBUTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757934 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002990 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention