BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7170098 · Received January 5, 2018

    Report

    Report Number
    2648035-2018-00037
    Event Type
    Injury
    Date Received
    January 5, 2018
    Report Date
    April 11, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT WAS LEARNED THIS IS AN INVESTIGATIONAL DEVICE AND IS NOT SAME OR SIMILAR TO PRODUCTS DISTRIBUTED/SOLD IN THE UNITED STATES, THEREFORE A SUPPLEMENTAL REPORT IS NOT REQUIRED AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER. IN THE INITIAL MDR PMA # (B)(4) WAS PROVIDED HOWEVER THIS IS NO LONGER APPLICABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S OPERATIVE EYE. POST-OPERATIVELY, 6 MONTHS AFTER SURGERY, THE PATIENT REPORTED BEING VERY BOTHERED BY HALOS WHEN DRIVING AT NIGHT AND DUSK/DAWN, WHICH CAUSED DIFFICULTY WITH ACTIVITIES SUCH AS SHOPPING AND SEEING CHRISTMAS LIGHTS ON THE RIVER. THE PATIENT ALSO COMPLAINED OF BEING EXTREMELY BOTHERED BY GLARE, LIGHT SENSITIVITY, STARBURSTS, WHICH CAUSED DIFFICULTY DRIVING THROUGHOUT THE DAY. ALSO, THE PATIENT COMPLAINED OF BEING MODERATELY BOTHERED BY OCCLUSIONS WHILE DRIVING AND POOR LOW LIGHT CONDITIONS WHEN DRIVING OR READING CLOSE UP. REPORTEDLY, THESE OUTCOMES HAVE SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13414 UNKNOWN MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other