BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR SIGHT KAMRA CORNEAL IMPLANT

    MDR report key: 6910847 · Received October 3, 2017

    Report

    Report Number
    MW5072564
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    June 9, 2016
    Report Date
    September 29, 2017
    Manufacturer
    ACUFOCUS INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASIK SURGERY ON BOTH EYES. INSERTION OF KAMRA CORNEAL INLAY INTO LEFT EYE BY DR. (B)(6) AT (B)(6) IN (B)(6). RIGHT EYE DISTANCE VISION IMPROVED, BUT WHEN READING, GHOST IMAGES APPEARED IN RIGHT EYE. THE LEFT EYE VISION DRAMATICALLY BECAME WORSE WITH BLURRED VISION, STARBURSTS, HALOS, INABILITY TO FOCUS OR READ AT BOTH DISTANCE OR UP CLOSE. LARGE "FLOATERS" APPEARED IN MY FIELD OF VIEW AND I HAD VERY POOR VISION WITHOUT BRIGHT LIGHT. SECOND AND THIRD SURGERIES WERE PERFORMED ON MY LEFT EYE BY DR. (B)(6) AND A SECOND SURGERY ON MY RIGHT EYE WAS PERFORMED. THE RIGHT EYE NEAR VISION IMPROVED, BUT THERE WAS A SLIGHT DEGRADING OF DISTANCE VISION. THE LEFT EYE NEAR VISION HAS IMPROVED AND I CAN NOW READ WITHOUT GLASSES, HOWEVER, MY NIGHT VISION IN MY LEFT EYE IS SO BAD THAT IF I LOSE MY VISION IN MY RIGHT EYE, I WILL NOT BE ABLE TO DRIVE AT NIGHT. SEVERE DRYNESS IS ALSO AN ISSUE, EVEN WITH TEAR DUCT PLUGS IN BOTH EYES, CONTINUOUS USE OF RESTASIS SOLUTION TWICE DAILY AND FREQUENT USE OF ARTIFICIAL TEARS THROUGHOUT THE DAY. HAIR AND NAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689394 CLEAR SIGHT KAMRA CORNEAL IMPLANT IMPLANT, CORNEAL REFRACTIVE LQE ACUFOCUS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other