BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENICON SF-P

    MDR report key: 185968 · Received September 3, 1998

    Report

    Report Number
    2950360-1998-00002
    Event Type
    Malfunction
    Date Received
    September 3, 1998
    Date of Event
    April 15, 1998
    Report Date
    August 14, 1998
    Manufacturer
    MENICON U.S.A.
    Product Code
    FPA
    Removal / Correction Number
    C0009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN FOR FITTING OF A NEW LENS AND AT THAT TIME SHE TOLD DOCTOR HER OLD LENS BROKE IN HER EYE. SHE DID NOT STATE WHEN THIS HAPPENED, JUST GAVE THE DOCTOR THE PIECES THAT SHE HAD AND THE DOCTOR EXAMINED HER EYE. NO INJURY WAS FOUND AND THE DOCTOR'S OFFICE DOUBTS THIS ACTUALLY OCURRED IN PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENICON SF-P CONTACT LENS FPA MENICON U.S.A. MADE TO ORDER S20160-SO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other