BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 325456 · Received April 6, 2001

    Report

    Report Number
    1119421-2001-00499
    Event Type
    Injury
    Date Received
    April 6, 2001
    Date of Event
    March 5, 2001
    Report Date
    March 8, 2001
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT A PATIENT COMPLAINED OF PAIN AND BLURRY VISION THREE WEEKS FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL). THE PATIENT'S VISION WAS 20/400 AND SLIT LAMP EXAMINATION REVEALED IRITIS, UVEITIS, AND MACULAR EDEMA. THE PT WAS SENT TO RETINAL SPECIALIST. A VITRECTOMY WAS PERFORMED IN 03/2001 FOR ENDOPHTHALMITIS. CULTURES GREW OUT STAPHYLOCOCCUS EPIDERMIDIS. THE SURGEON STATES THAT THE ENDOPHTHALMITIS WAS PROBABLY UNRELATED TO THE IOL. THE PT IS IMPROVING AND THEIR VA IN 03/2001 WAS 20/60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15146 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON MA30BA 588247

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention