BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 610982 · Received June 3, 2005

    Report

    Report Number
    1119421-2005-00208
    Event Type
    Other
    Date Received
    June 3, 2005
    Report Date
    May 6, 2005
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED FOLLOWING EXAMINATION OF THE PT IN 08/2005. DURING THE SLIT LAMP EXAM, SCUFF MARKS WERE OBSERVED AT THE 2-4 AND 8-10 O'CLOCK POSITION WHICH LOCKED LIKE DENSELY PACKED CONCENTRIC RING PORTIONS. THE REST OF THE LENS WAS CLEAR. THE SCRUFF MAKRS WERE IDENTIFIED AS A POSSIBLE CONTRIBUTING FACTOR TO THE PT'S CONTINUING GLARE SYMPTOMS. THE GLARE SYMPTOMS BECAME WORSE FOR THE PT FOLLOWING YAG. ALTHOUGH THE PT'S VA IS GOOD, DRIVING AT NIGHT IS SEROIUSLY IMPAIRED BECAUSE HE HAS TO KEEP HIS LEFT EYE CLOSED AND SOLELY RELIES ON HIS RIGHT EYE.

    Description of Event or Problem · 1

    SURGEON STATES PATIENT REPORTS GLARE AT NIGHT AFTER CATARACT EXTRACTION AND INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IT WAS REPORTED THAT THE IOL APPEARED TO HAVE DEPOSITS EITHER ON THE LENS SURFACE OR IN THE LENS. A YAG CAPSULOTOMY WAS PERFORMED AT 6 MONTHS POST OP WITH NO IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SA60AT 814384

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other