BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION LENS

    MDR report key: 4142541 · Received October 1, 2014

    Report

    Report Number
    1119279-2014-00237
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE LENS WAS REMOVED FROM THE PATIENT'S LEFT EYE DUE TO INFLAMMATION POST IOL IMPLANT. TREATMENT INCLUDED ANTIBIOTICS AND ANTERIOR CHAMBER IRRIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. REFERENCE MDR# 1119279-2014-00236 FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611550 AKREOS MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60P 1440905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other