BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS SINGLE USE INSERTION DEVICE

    MDR report key: 3113733 · Received May 10, 2013

    Report

    Report Number
    1119279-2013-00151
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    KYB
    PMA / PMN Number
    K063694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UPON LENS INSERTION LACK OF POSTERIOR CAPSULAR SUPPORT WAS OBSERVED. THE SURGEON CUT AND REMOVED THE LENS. A VITRECTOMY WAS PERFORMED AND ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. IN THE SURGEON'S OPINION THE LIKELY CAUSE OF THE EVENT WAS ZONULAR WEAKNESS. THE PT IS REPORTEDLY DOING WELL, POST-OP BCVA WAS 20/30-2, AND PT'S VISUAL ACUITY CONTINUES TO IMPROVE. PLEASE REFERENCE MDR# 1119279-2013-00150 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205310 AKREOS SINGLE USE INSERTION DEVICE IOL INSERTER/INJECTOR KYB BAUSCH & LOMB AI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other AO60G INTRAOCULAR LENS