BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3023797 · Received March 26, 2013

    Report

    Report Number
    1119279-2013-00083
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RETURNED TO BAUSCH + LOMB FOR EVAL. 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 THE INTRAOCULAR LENS WAS INSERTED AND REMOVED INTRAOPERATIVELY FROM THE PT'S EYE DUE TO A RUPTURED CAPSULE. THE LENS BEGAN TO FAIL THROUGH THE POSTERIOR SIDE OF THE CAPSULE AND HAD TO BE REMOVED. A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER LENS WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE SURGEON, THE PT'S CURRENT PROGNOSIS IS STABLE. PLEASE REFERENCE MDR # 1119279-2013-00082 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123092 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other SOFPORT ADVANCED OPTIC LENS (B+L), LI61AOR