BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION LENS

    MDR report key: 2831528 · Received November 5, 2012

    Report

    Report Number
    1119279-2012-00266
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    THE SURGEON REPORTED THAT THE ANTERIOR SURFACE OF THE MI60LUS LENS LOOKED GRAY WITH "GROUND GLASS" APPEARANCE, SIX WEEKS POST IMPLANTATION. YAG LASER SURGERY WAS PERFORMED SUCCESSFULLY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS MICRO INCISION LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB MI60LUS 1210812

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other