BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 3971590 · Received July 31, 2014

    Report

    Report Number
    2648035-2014-00381
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    November 30, 2011
    Report Date
    June 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT IS EXPERIENCING REFLEXES IN VISION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THEY NOTED REFLEXES IN THE VISION OF RIGHT EYE, TWO (2) DAYS AFTER SURGERY. PATIENT STATED WHEN THE LIGHTS REFLECT IN PERIPHERAL VISION, THEY LOSE THEIR VISION, AND DURING THE NIGHT THE SITUATION IS WORSE. PATIENT STATED HE CAN´T DRIVE AND WALK THE STREETS, AND ALSO WHEN HE WATCHES TV, IS NECESSARY TO TURN OFF THE HOME LIGHTS AS TO NOT DISRUPT VISION WITH LATERAL LIGHTS (PERIPHERAL VISION). IN ADDITION, PATIENT IS STILL NOTING REFLEXES AND PHYSICIAN (DR. (B)(6)) DOESN´T KNOW WHY. IT IS UNKNOWN IF THE PATIENT PLANS TO HAVE LENS EXPLANTED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448177 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other