BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 558730 · Received December 2, 2004

    Report

    Report Number
    1119421-2004-00417
    Event Type
    Other
    Date Received
    December 2, 2004
    Report Date
    November 1, 2004
    Manufacturer
    ALCON LABS INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    AN ATTORNEY REPRESENTING THE PT SENT A LETTER ALLEGING THAT THE PT SUFFERED DAMAGES AS A RESULT OF A DEFECTIVE INTRAOCULAR LENS. A REVIEW OF THE MEDICAL RECORDS REVEALS THAT ON THE FIRST POSTOPERATIVE DAY, THE SURGEON NOTED SOME MILD CORNEAL EDEMA. THE CORNEAL EDEMA RESOLVED AND THE PT HAD A UNEVENTFUL POSTOPERATIVE COURSE. DURING THEIR MOST RECENT EXAMINATION (2004), THE PT'S BEST CORRECTED VISUAL ACUITY OD WAS 20/20-1. THE PT COMPLAINED OF BLURRED VISION OU (OS>OD) AND REPORTED THAT DAY AND NIGHT VISION WAS DECREASING. THEY EXHIBITED SOME REDNESS AND IRRITATION AND CONTINUES TO COMPLAIN OF DRY EYES. WHEN THEY USE ARTIFICIAL TEARS, THE PT STATES EVERYTHING IS BLURRED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABS INC./HUNTINGTON SA60AT 792619

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 2004--MOST RECENT EYE EXAMINATION.| NO MEDICATIONS.