BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AI-28 DELIVERY SYSTEM

    MDR report key: 3132990 · Received May 23, 2013

    Report

    Report Number
    1119279-2013-00164
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    KYB
    PMA / PMN Number
    K063694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS NOT RETURNED TO B+L FOR EVAL; THEREFORE, PRODUCT EVAL COULD NOT BE CONDUCTED. THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. BASED ON THE INFO AVAILABLE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS A PRE-EXISTING PT CONDITION WHICH RESULTED FROM AN INTRAVITREAL INJECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS INTRAOPERATIVELY REMOVED FROM THE PT'S LEFT EYE DUE TO POSTERIOR CAPSULE DEFECT. ACCORDING TO THE SURGEON THE CAPSULE DEFECT WAS MOST LIKELY A PRE-EXISTING PT CONDITION (CAPSULE DEFECT) WHICH RESULTED FROM AN INTRAVITREAL INJECTION. THE PRE-EXISTING DEFECT ENLARGED AFTER THE IOL WAS INSERTED INTO THE BAG. VITRECTOMY WAS PERFORMED AND AN LI61 INTRAOCULAR LENS WAS PLACED IN THE SULCUS AS A REPLACEMENT. PLEASE REFERENCE MDR#: 1119279-2013-00163 FOR THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228673 AI-28 DELIVERY SYSTEM KYB/LENS, GUIDE, INTRAOCULAR KYB BAUSCH & LOMB AI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other AKREOS AO INTRAOCULAR LENS (B+L)