BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION INTRAOCULAR LENS

    MDR report key: 3830207 · Received May 1, 2014

    Report

    Report Number
    1119279-2014-00074
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. 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 DURING FOLLOW UP EXAM WITH SLIT LAMP A WHITE MEMBRANE AROUND THE IOL WAS DETECTED. THE DOCTOR SUSPECTS THE EVENT AS TASS (TOXIC ANTERIOR SEGMENT SYNDROME). TREATMENT INCLUDES ANTIBIOTICS AND ANTERIOR CHAMBER IRRIGATION. THIS REPORT IS IN REFERENCE TO THE PATIENT'S RIGHT EYE. REFERENCE 1119279-2014-00075 FOR THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261664 AKREOS MICRO INCISION INTRAOCULAR LENS HQL BAUSCH & LOMB MI60 1370408

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other