BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2023826-2018-01693

    MDR report key: 8090056 · Received November 20, 2018

    Report

    Report Number
    2023826-2018-01693
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    October 22, 2018
    Report Date
    October 25, 2018
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS RETURNED IN LIQUID, IN THE LENS CASE/VIAL. VISUAL INSPECTION FOUND TEARS IN THE HAPTIC. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM TMICL13.2 LENS, -8.5/+2.0/111 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENS DUE TO OVER VAULTING. THE PROBLEM WAS RESOLVED. "NO PATIENT INJURY" IS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention