BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6986209 · Received October 29, 2017

    Report

    Report Number
    3005956347-2017-00133
    Event Type
    Malfunction
    Date Received
    October 29, 2017
    Date of Event
    May 30, 2017
    Report Date
    October 29, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. INLAY SHIFTS IN POSITION IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. COMPLAINT REFERENCE #: (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. THE INLAY WAS REPOSITIONED TWICE EARLY IN THE POSTOPERATIVE PERIOD (ON (B)(6) 2017 AND (B)(6) 2017) PRESUMABLY TO ADDRESS INLAY DECENTRATION. THE PATIENT REPORTED BEING DISSATISFIED AND THERE WAS SOME INFLAMMATION. THE INLAY WAS EXPLANTED ON (B)(6) 2017; HOWEVER, THE SERIOUSNESS OF THE INFLAMMATION, IMPACT ON VISION, AND REASON FOR EXPLANT ARE NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765553 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 003071 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR