BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT CELL

    MDR report key: 362368 · Received November 16, 2001

    Report

    Report Number
    2083373-2001-00001
    Event Type
    Injury
    Date Received
    November 16, 2001
    Date of Event
    October 1, 2001
    Report Date
    November 8, 2001
    Manufacturer
    M-PACT CORP
    Product Code
    HOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMED ABOUT 30 LASIK PROCEDURES WITH SPONGES FROM ONE LOT AND NOTICED 12-14 EYES WITH (DLK) DIFFUSE LAMELLAR KERATITIS. MD HAD TO LIFT FLAPS IN TWO EYES AND INCREASED FOLLOW-UP CARE FOR OTHER EYES. SURGEON CONCLUDED THAT SPONGES FROM ONE LOT ARE MOST LIKELY THE CAUSE OF INCREASED DLK. WORST CASES OF DLK WERE ON ENHANCEMENTS AFTER USING THE SPONGES TO PUSH BACK THE EPITHELIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52125 SOFT CELL PVA FOAM SPONGES HOZ M-PACT CORP 0525 1220C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other