BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 323040 · Received March 26, 2001

    Report

    Report Number
    1119421-2001-00427
    Event Type
    Injury
    Date Received
    March 26, 2001
    Date of Event
    February 14, 2001
    Report Date
    March 22, 2001
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    1119421-3/5/01-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTING SURGEON. THE PT EXPERIENCED MODERATE INFLAMMATION IMMEDIATELY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, LASTING THREE WEEKS. THE PT'S VISUAL ACUITY (VA) PRIOR TO IOL IMPLANTATION WAS 20/100 (2/2001). AFTER THE IOL IMPLANTATION, THE PT'S VA WAS 20/25 (3/2001). THE SURGEON INDICATED THE INFLAMMATION WAS PROBABLY DUE TO THE YOUNG AGE OF THE PT AND NOT RELATED TO THE IOL. THE PT'S CONDITION IS CURRENTLY STABLE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PT REC'D AN INTRAOCULAR LENS IMPLANT. DURING A F/U VISIT, IT WAS NOTED THE LENS APPEARED CLOUDY. THE SURGEON PRESCRIBED ANTIBIOTIC AND STEROID THERAPY. NO OTHER INFO REGARDING THE EVENT WAS PROVIDED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13224 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON MA60BM 616923

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention