BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2023826-2019-00422

    MDR report key: 8417312 · Received March 13, 2019

    Report

    Report Number
    2023826-2019-00422
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Report Date
    February 13, 2019
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN UPCOMING REMOVAL AND REPLACEMENT OF A TORIC ICL THAT ROTATED WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patients

    Seq Age Sex Outcome Treatment
    1