BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION LENS

    MDR report key: 2396909 · Received December 29, 2011

    Report

    Report Number
    1119279-2011-00273
    Event Type
    Injury
    Date Received
    December 29, 2011
    Date of Event
    May 16, 2011
    Report Date
    November 7, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED IN THE EYE; THEREFORE IT IS NOT AVAILABLE 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 THE PT PRESENTED WITH REBOUND INFLAMMATION APPROX ONE MONTH AFTER AKREOS MI60 IMPLANTATION IN THE LEFT EYE. THE SURGEON WAS UNCERTAIN ABOUT THE CAUSE OF THE INFLAMMATION. THE PT WAS PRESCRIBED STEROIDS FOR INFLAMMATION TREATMENT. YAG CAPSULOTOMY WAS PERFORMED THREE MONTHS AFTER IOL IMPLANT FOR POSTERIOR CAPSULAR OPACIFICATION (PCO) ON (B)(6) 2011. THE PT'S PROGNOSIS AS OF (B)(6) 2011 WAS "QUIET UVEITIS, BUT STEROID RESPONSE WITH ELEVATED INTRAOCULAR PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60L 1030108

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other