BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1053096 · Received May 23, 2008

    Report

    Report Number
    1119421-2008-00367
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 23, 2008
    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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TH 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 05/01/2008, 05/02/2008 AND 05/08/2008 BY PHONE, MAIL AND FAX. ADDITIONAL INFORMATION WAS RECEIVED 05/02/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON 05/23/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS BLURRY VISION AT ALL DISTANCES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATES HER VISION IS BETTER SINCE SURGERY AND SHE SEES WELL WITH GLASSES ON, BUT SHE BELIEVED SHE WOULD NOT NEED GLASSES EXCEPT TO READ SMALL PRINT. THE CONSUMER HAS A HISTORY OF GLAUCOMA AND HAD HIGH IOP FOLLOWING SURGERY BECAUSE SHE WAS TOLD TO DISCONTINUE HER MEDICATION EARLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN60T4 10721415

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other TRAVATAN| ARTIFICIAL TEARS| PRED FORTE