BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION LENS

    MDR report key: 3102081 · Received April 26, 2013

    Report

    Report Number
    1119279-2013-00139
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    September 11, 2012
    Report Date
    March 28, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 ONE MONTH AFTER SUCCESSFUL IMPLANTATION OF THE MI60 INTRAOCULAR LENS, THE PT PRESENTED WITH FIBRIN FORMATION AND LOW GRADE POSTERIOR SEGMENT INFLAMMATION. A VITRECTOMY WAS PERFORMED ON (B)(6) 2012 AND THE PT WAS TREATED WITH ANTI-INFLAMMATORIES. A VITREOUS SAMPLE WAS OBTAINED AND TESTED FOR CULTURE AND SENSITIVITY, THE RESULTS WERE NEGATIVE. PT'S PROGNOSIS IS GOOD WITH CONTINUED ANTI-INFLAMMATORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181978 AKREOS MICRO INCISION LENS HQL BAUSCH & LOMB MI60 1205921

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other