BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISOL CORNEAL STORAGE MEDIA

    MDR report key: 879660 · Received July 11, 2007

    Report

    Report Number
    1920664-2007-00802
    Event Type
    Injury
    Date Received
    July 11, 2007
    Date of Event
    November 22, 2005
    Report Date
    June 14, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYX
    PMA / PMN Number
    K894162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN COMPLETED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT ALLEGES VISION LOSS RESULTING FROM AN IMPLANTED DONOR CORNEA ALLEGEDLY CONTAMINATED BY THIS STORAGE MEDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISOL CORNEAL STORAGE MEDIA CORNEAL STORAGE MEDIA LYX BAUSCH & LOMB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other