BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEPENDENT CORNEAL VIEWING CHAMBER

    MDR report key: 3313026 · Received August 22, 2013

    Report

    Report Number
    1119279-2013-00268
    Event Type
    Injury
    Date Received
    August 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    July 23, 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

    THE INITIAL REPORTER HAS INDICATED THAT THE EVENT IS MORE LIKELY DUE TO PATIENT-RELATED FACTORS, AS THE PATIENT HAD A HISTORY OF MULTIPLE OCULAR PROBLEMS. ACCORDING TO THE INITIAL REPORTER, THIS EVENT WAS REPORTED TO THE FDA BY OCULAR SYSTEMS, INC. AS MFR REPORT # 3005357288-2013-00001. 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 PATIENT UNDERWENT DSEK SURGERY DUE TO PSEUDOPHAKIC BULLOUS KERATOPATHY (PBK) ON (B)(6) 2012. THE DONOR CORNEA (1928-12) HAD BEEN STORED IN AN IVC-12 VIEWING CHAMBER. APPROXIMATELY 4 WEEKS POST-OPERATIVELY, THE PATIENT PRESENTED WITH ENDOPHTHALMITIS. A DIAGNOSTIC VITRECTOMY WAS PERFORMED AND THE VITREOUS FUNGAL CULTURE WAS POSITIVE FOR CANDIDA GLABRATA. ORAL AND INTRAVITREAL ANTIFUNGALS WERE ADMINISTERED. ACCORDING TO THE TRANSPLANT SURGEON, THE CORNEA REMAINS CLEAR WITH PRECIPITATES AND THE PATIENT IS WITHOUT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409124 INDEPENDENT CORNEAL VIEWING CHAMBER INDEPENDENT VIEW CHAMBER LYX BAUSCH & LOMB IVC-12 U8230

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other NON-STERILE HUMAN DONOR CORNEA