BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISOL-GS CORNEA STORAGE MEDIA

    MDR report key: 2706279 · Received August 15, 2012

    Report

    Report Number
    1119279-2012-00173
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    June 19, 2012
    Report Date
    July 16, 2012
    Manufacturer
    ALLIANCE MEDICAL PRODUCTS
    Product Code
    LYX
    PMA / PMN Number
    K924165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INITIAL REPORTER SENT REPORT TO FDA UNDER REPORT #: (B)(4). 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 TWO PTS ((B)(6)) RECEIVED CORNEA TRANSPLANTS FROM THE SAME DONOR ((B)(6)). PT (B)(6) HAD PREOPERATIVE DIAGNOSIS OF KERATOCONUS. THE PT PRESENTED WITH POSTOPERATIVE ACUTE IRITIS, DENSE VITREOUS DEBRIS AND MEMBRANE FORMATION. BECAUSE THE DONOR CORNEAL RIM CULTURE WAS POSITIVE FOR ENTEROCOCCUS, THE PT WAS GIVEN VANCOMYCIN INTRAVITREAL INJECTION AS A PRECAUTIONARY TREATMENT. A VITREOUS SAMPLE CULTURE WAS NEGATIVE AND PT STATUS IMPROVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR PT (B)(6). PLEASE REFERENCE MDR#: 1119279-2012-00172 FOR PT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISOL-GS CORNEA STORAGE MEDIA CORNEA STORAGE MEDIA LYX ALLIANCE MEDICAL PRODUCTS 50006-OPT W0006177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NON-STERILE HUMAN DONOR CORNEA| ANTI-REJECTION DROPS