BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEPENDENT CORNEAL VIEWING CHAMBER

    MDR report key: 2757432 · Received September 20, 2012

    Report

    Report Number
    1119279-2012-00207
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    June 28, 2012
    Report Date
    August 20, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYX
    PMA / PMN Number
    K921729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE LOT HISTORY RECORD AND THE STERILIZATION BATCH RECORD WERE REVIEWED FOR LOT NUMBER U7933 AND NO DISCREPANCIES OR DEVIATIONS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT WERE NOTED. ALL END-PRODUCT RELEASE CRITERIA WERE MET. THE STERILIZATION CYCLE AND PARAMETERS MET THE ACCEPTANCE CRITERIA. OUR INVESTIGATION REVEALED THAT THE IVC-12 CORNEAL VIEWING CHAMBER WAS MANUFACTURED WITHIN SPECIFICATIONS AND THERE IS NO EVIDENCE OF ANY DEFECT IN THE STERILITY RECORDS. BASED ON THE CURRENT INFO, THE SPECIFIC ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. THIS EVENT HAS BEEN PREVIOUSLY REPORTED ON MANUFACTURER'S REPORT NUMBER 1119279-2012-00172 FOR OPTISOL-GS CORNEA STORAGE MEDIA.

    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) 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 ENUCLEATION WAS PERFORMED ON (B)(6) 2012. THIS REPORT IS FOR PT (B)(6) INVOLVING THE PT'S RIGHT EYE. PLEASE REFERENCE MDR #: 1119279-2012-00208 FOR PT (B)(6). ON (B)(4) 2012, ADDITIONAL INFO WAS RECEIVED INDICATING THAT THE CORNEAS HAD BEEN STORED IN IVC-12 CORNEAL VIEWING CHAMBERS. PER THE REPORTER, THE IVC-12 CORNEAL VIEWING CHAMBERS APPEARED TO BE SEALED PROPERLY, AND WERE DESCRIBED AS LOOKING GOOD. NO CULTURES WERE TAKEN PRIOR TO STORING THE CORNEAS IN OPTISOL GS CORNEA STORAGE MEDIA OR IVC-12 CORNEAL VIEWING CHAMBERS. THE REPORTER ALSO INDICATED THAT THERE WERE NO ROUTINE CULTURES PERFORMED UPON HARVESTING THE CORNEAS FROM THE DONOR AS CORNEAS ARE NON-STERILE TISSUE. THE RIM CULTURE OF CORNEA (B)(6) WAS DONE BY THE SURGEON AT THE TIME OF TRANSPLANT PER SURGEON'S ROUTINE PROCEDURE. THE PT'S PREOPERATIVE BCVA WAS COUNTING FINGERS. PT'S BCVA DECREASED TO HAND MOTION AS OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENT CORNEAL VIEWING CHAMBER INDEPENDENT VIEW CHAMBER LYX BAUSCH + LOMB IVC-12 U7933

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S NON-STERILE HUMAN DONOR CORNEA| ANTI-REJECTION DROPS, AND| OPTISOL-GS CORNEA STORAGE MEDIA