BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISOL-GS CORNEA STORAGE MEDIA

    MDR report key: 2706273 · Received August 15, 2012

    Report

    Report Number
    1119279-2012-00172
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    June 20, 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 USING MFR REPORT #: 1000517466-0037-12. 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)(4)) RECEIVED CORNEA TRANSPLANTS FORM THE SAME DONOR ((B)(4)). PT (B)(4) DEVELOPED ENDOPHTHALMITIS. ENTEROCOCCUS WAS IDENTIFIED ON THE DONOR CORNEA RIM CULTURE. PT WAS TREATED WITH VANCOMYCIN AND VITRECTOMY; HOWEVER THE INFECTION DID NOT CLEAR AND PT WAS ENUCLEATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR PT (B)(4) INVOLVING THE PT'S RIGHT EYE. PLEASE REFERENCE MDR#: 1119279-2012-00173 FOR PT (B)(4).

    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 70 YR Other ANTI-REJECTION DROPS| NON-STERILE HUMAN DONOR CORNEA