BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 637288 · Received September 23, 2005

    Report

    Report Number
    1119421-2005-00305
    Event Type
    Other
    Date Received
    September 23, 2005
    Report Date
    August 25, 2005
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAS COMPLAINTS OF GLARE. THIS PATIENT USES A COMPUTER IN THEIR LINE OF WORK AND IS HAVING DIFFICULTY READING THE SCREEN DUE TO THE GLARE. THE SURGEON INDICATED THE IOL HAS MICROVACUOLES AND THEY ARE CONCERNED THAT IS THE CAUSE FOR THE PATIENT'S GLARE SYMPTOMS. HOWEVER, THEY ALSO STATED THIS PATIENT HAS DIABETES WITH VASCULAR PERFUSION IN OTHER AREAS OF THEIR BODY WHICH COULD BE CONTRIBUTING TO THE PATIENT'S GLARE SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES SA30AT 857464

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other