BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS LENS

    MDR report key: 2980469 · Received February 22, 2013

    Report

    Report Number
    1119279-2013-00052
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    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

    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 IOL WAS EXPLANTED APPROXIMATELY 2 YEARS AND 10 MONTHS POST IMPLANTATION DUE TO OPACIFICATION/DISCOLORATION. THE MODEL AND LOT NUMBER OF THE LENS ARE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77273 AKREOS LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other