BEUDAMED
    FDA Adverse Event Summary report: N

    BIO-COR 12 HOUR

    MDR report key: 11436 · Received February 14, 1994

    Report

    Report Number
    MW1000719
    Date Received
    February 14, 1994
    Date of Event
    January 12, 1994
    Report Date
    February 9, 1994
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT 3 PTS DEVELOPED EYE INFECTIONS AFTER IMPLANTATION OF AN INTRAOCULAR LENS. ALL EQUIPMENT AND SUPPLIED USED DURING THE SURGERIES WERE EXAMINED. THE STERILIZER CONTROLS WERE CORRECT. ALL SOLUTIONS USED DURING THE PROCEDUES WERE CULTURED; RESULTS WERE NEGATIVE. THE REPORTER OPENED A SEALED PACKAGE OF BIO-COR AND CULTURED THE PRODUCT; CULTURE RESULTS WERE COAGULASE NEGATIVE STAPHYLOCOCUS. THE PTS RECEIVED TREATMENT AND HAD NO FURTHER PROBLEMS. EVENT OCCURRED ON 1/12/94 AND 2/2/94. PTS WERE AN 81-YR-OLD MALE, AND 86-YR-OLD MALE AND A 75-YR-OLD FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-COR 12 HOUR LYX BAUSCH & LOMB DHR3088

    Patients

    Seq Age Sex Outcome Treatment
    1 *