BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AOSEPT CUP/DISC

    MDR report key: 229389 · Received June 2, 1999

    Report

    Report Number
    1053053-1999-00004
    Event Type
    Malfunction
    Date Received
    June 2, 1999
    Date of Event
    May 4, 1999
    Report Date
    June 2, 1999
    Manufacturer
    ATRION MEDICAL
    Product Code
    LYL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION INVOLVING ONE PERSON. UPON STORING HER LENS THE CUSTOMER HEARD A "CRACKING" SOUND AND FOUND THAT THE LENS CUP HAD FRACTURED. THE LENSES THEMSELVES WERE NOT DAMAGED. NO PERSONAL INJURY OR PROPERTY DAMAGE OCCURRED. LOT NUMBER WAS NOT AVAILABLE, AND CUP IS NOT AVAILABLE FOR RETURN. DATE AOSPET CUP/DISC DISPENSED: 5/3/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AOSEPT CUP/DISC LENS CARE CUP/NEUTRALIZER DISC LYL ATRION MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN