BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENICON SF-P

    MDR report key: 185982 · Received September 3, 1998

    Report

    Report Number
    2950360-1998-00005
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    June 16, 1998
    Report Date
    August 14, 1998
    Manufacturer
    MENICON U.S.A.
    Product Code
    LPL
    Removal / Correction Number
    C0033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TRYING TO REMOVE THE LENS FROM HER EYE WHEN IT BROKE. PT WENT IMMEDIATELY TO HER DOCTOR. THERE WAS NO INJURY TO PT'S EYE. PT WAS LATER FIT WITH A NEW LENS. THERE ARE NO PROBLEMS BECAUSE OF THIS INCIDENT . THE LENS BROKE INTO 3 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENICON SF-P CONTACT LENS LPL MENICON U.S.A. MADE TO ORDER S20120-SO-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other