BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1912825 · Received November 5, 2010

    Report

    Report Number
    1119421-2010-01216
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/12/2010, 10/14/2010, AND 10/19/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 10/07/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS EXPERIENCED BLURRY VISION AND A SENSATION LIKE THE CORNER OF HER EYELID IS BEING PULLED DOWN. THE CONSUMER FORWARDED A LETTER FROM A CONSULTING SURGEON THAT SAW HER AS A SECOND OPINION. ACCORDING TO THIS SURGEON, THE CONSUMER REPORTED A "RAINBOW SHIMMER PHENOMENON AND PROBLEMS WITH TEMPORAL DYSPHOTOPSIA." THE SURGEON NOTED THE CONSUMER HAD CHRONIC IRRITATION AND DISCOMFORT IN HER EYE. THE CONSULTING SURGEON FELT THE CONSUMER'S PROBLEMS WERE RELATED TO HER RESIDUAL REFRACTIVE ERROR. THE PATIENT'S BCVA WAS NOTED TO BE 20/20. THE SURGEON WAS GOING TO GIVE THE CONSUMER A TRIAL OF CONTACT LENSES TO SEE IF HER SYMPTOMS WOULD RESOLVE WHEN THE REFRACTIVE ERROR WAS CORRECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10818209

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other