BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISOL-GS CORNEA STORAGE MEDIA

    MDR report key: 3095344 · Received May 3, 2013

    Report

    Report Number
    1119279-2013-00145
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYX
    PMA / PMN Number
    K924165
    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 A DONOR CORNEA ((B)(6)) HARVESTED FROM A DECEASED DONOR ON (B)(6) 2013 WAS STORED IN OPTISOL GS AND IVC-12 VIEWING CHAMBER. NO CULTURES WERE TAKEN AT THE TIME OF HARVESTING. THE CORNEA WAS THEN SHIPPED TO ANOTHER COMPANY TO BE CUT FOR A DSAEK PROCEDURE. DURING THIS PROCESS THE CORNEA WAS REMOVED FORM THE VIEWING CHAMBER AND CUT AND THEN PLACED. IN ANOTHER IVC-12 VIEWING CHAMBER WITH OPTISOL GS. ON (B)(6) 2013 THE CORNEA WAS TRANSPLANTED AND A RIM CULTURE WAS PERFORMED. THE CULTURE OF THE CORNEA PERFORMED BY THE TRANSPLANT SURGEON AT THE TIME OF SURGERY WAS POSITIVE FOR CANDIDA. ON (B)(6) 2013 (APPROXIMATELY 6 WEEKS AFTER THE TRANSPLANT), THE PT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND WAS RE-TRANSPLANTED ON (B)(6) 2013. THE SURGEON CULTURED CANDIDA FROM THE RECIPIENT EYE AT THE TIME OF RE-TRANSPLANT. THIS MDR REPORT IS FOR THE FIRST LOT OF OPTISOL GS USED FOR STORAGE. PLEASE REFERENCE MDR#: 1119279-2013-00146 FOR THE SECOND LOT OF OPTISOL GS USED FOR STORAGE. PLEASE REFERENCE MDR#: 1119279-2013-00147 FOR THE IVC-12 VIEWING CHAMBERS USED FOR STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194689 OPTISOL-GS CORNEA STORAGE MEDIA LYX/CORNEA STORAGE MEDIA LYX BAUSCH + LOMB 500006-OPT W0006504

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other IVC-12 VIEWING CHAMBER| OPTISOL-GS CORNEA STORAGE MEDIA| NON-STERILE HUMAN DONOR CORNEA