BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISOL-GS CORNEA STORAGE MEDIA

    MDR report key: 3095361 · Received May 3, 2013

    Report

    Report Number
    1119279-2013-00146
    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 RETRANSPLANTED ON (B)(6) 2013. THE SURGEON CULTURE CANDIDA FROM THE RECIPIENT EYE AT THE TIME OF RETRANSPLANT. THIS MDR REPORT IS FOR THE FIRST LOT OF OPTISOL GS USED FOR STORAGE. PLEASE REFERENCE MDR#: 1119279-2013-00145 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
    194496 OPTISOL-GS CORNEA STORAGE MEDIA LYX/CORNEA STORAGE MEDIA LYX BAUSCH + LOMB 50006-OPT W0006580

    Patients

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