BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3082466 · Received April 24, 2013

    Report

    Report Number
    1119279-2013-00134
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS RETURNED TO BAUSCH+LOMB FOR EVAL. INVESTIGATION OF THIS EVENT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S RIGHT EYE DUE TO A POSTERIOR CAPSULE TEAR. ACCORDING TO THE SURGEON, THE TEAR WAS CAUSED BY SUDDEN PT MOVEMENT. VITRECTOMY WAS PERFORMED AND SUTURE WAS USED TO CLOSE THE WOUND. NO IOL WAS IMPLANTED BECAUSE A CHOROIDAL HEMORRHAGE DEVELOPED INTRAOPERATIVELY. THE SURGEON INDICATED THE POSSIBILITY OF LENS PLACEMENT IN THE FUTURE DEPENDING ON THE RESOLUTION OF CHOROIDAL HEMORRHAGE. PLEASE REF MDR #1119279-2013-00133 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177248 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other LI61AOR SOFPORT ADVANCED OPTIC LENS (B+L)