BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 3182228 · Received June 14, 2013

    Report

    Report Number
    1119279-2013-00191
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN RECEIVED 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 LENS WAS INSERTED AND REMOVED INTRAOPERATIVELY AS THE SURGEON NOTICED A SMALL "VACUOLE" IN THE LENS UPON INJECTION. INCISION WAS ENLARGED, ANOTHER LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY, AND NO SUTURES WERE NECESSARY. PT CURRENT PROGNOSIS IS EXCELLENT. THIS REPORT PERTAINS TO THE PT'S RIGHT EYE. PLEASE REF MDR#: 1119279-2013-00192 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271526 AKREOS ADVANCED OPTICS ASPHERIC LENS HQL BAUSCH & LOMB AO60P 1345427

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other VISCOJECT 2.2 DELIVERY SYSTEM