BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1414864 · Received June 26, 2009

    Report

    Report Number
    1119421-2009-00612
    Event Type
    Other
    Date Received
    June 26, 2009
    Date of Event
    August 1, 2003
    Report Date
    May 27, 2009
    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
    CA, 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 05/28/2009, 05/29/2009, 06/04/2009, 06/08/2009, 06/11/2009, 06/12/2009, 06/12/2009, 06/15/2009, AND 06/23/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/26/2009.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SINCE HER INTRAOCULAR LENS (IOL) IMPLANT SURGERY SIX YEARS PRIOR, HER EYE HAS BEEN SWOLLEN, WATERY, PAINFUL AND CONSUMER REPORTED EXPERIENCING A FOREIGN BODY SENSATION. THE SURGEON REPORTED THAT THE CONSUMER HAS CYSTOID MACULAR EDEMA FOLLOWING SURGERY THAT WAS TREATED WITH MEDICATIONS. THE SURGEON FURTHER REPORTED THAT HE HAD DIAGNOSED THE CONSUMER WITH STEROID INDUCED GLAUCOMA. THE CONSUMER WAS SEEN BY A RETINAL SPECIALIST TWO YEARS FOLLOWING IOL IMPLANT SURGERY, WHO REPORTED SOME TRUNCATION OF FOVEAL MARGINS BUT NO CYSTOID MACULAR EDEMA. 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 SA60AT 667480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other