BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDEPENDENT CORNEAL VIEWING CHAMBER

    MDR report key: 3255609 · Received July 26, 2013

    Report

    Report Number
    1119279-2013-00239
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    January 17, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYX
    PMA / PMN Number
    K921729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT DSEK SURGERY FOR FUCH'S DYSTROPHY ON (B)(6) 2012. THE DONOR CORNEA ((B)(4)) HAD BEN STORED IN AN IVC-12 VIEWING CHAMBER. THE DONOR RIM WAS CULTURED ONE DAY AFTER SURGERY AND WAS POSITIVE FOR "LIGHT GROWTH OF YEAR." THE RECIPIENT PRESENTED WITH AN INFECTION; AN AQUEOUS HUMOR FUNGAL CULTURE COLLECTED ON (B)(6) 2013 TESTED POSITIVE ON FUNGUS (CANDIDA SPECIES, NOT ALBICANS, GLABRATA, TROPICALIS OR KRUSEI). ACCORDING TO THE TRANSPLANT SURGEON, THE RECIPIENT'S CONDITION WORSENED ADN THE RECIPIENT UNDERWENT PENETRATING KERATOPLASTY (PKP) SURGERY ON (B)(6) 2013, REPLACING THE DSEK GRAFT. THE RECIPIENT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351141 IDEPENDENT CORNEAL VIEWING CHAMBER INDEPENDENT VIEW CHAMBER LYX BAUSCH & LOMB IVC-12 U8812

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other NON-STERILE HUMAN DONOR CORNEA