BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 772498 · Received October 20, 2006

    Report

    Report Number
    1119421-2006-00356
    Event Type
    Other
    Date Received
    October 20, 2006
    Report Date
    September 22, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND MAIL ON 9/25/2006. TELEPHONE FOLLOW-UP WAS CONDUCTED ON 10/05/2006. TO DATE, A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A PATIENT CALLED TO REPORT, THAT SHE IS EXPERIENCING BLURRED NEAR AND DISTANCE VISION, FOLLOWING BILATERAL INTRAOCULAR LENS IMPLANT SURGERIES. ADAPTATION WAS DISCUSSED WITH THE PATIENT AND SHE STATED, SHE WOULD CALL BACK IF HER VISION DID NOT IMPROVE. TELEPHONE FOLLOW-UP WAS CONDUCTED AND THE SURGEON FEELS IT IS TOO SOON FOLLOWING THE SURGERIES TO COMMENT ON THE PATIENT'S OUTCOME. MDR# 1119421-2006-00355 - OS (LEFT EYE), MDR# 1119421-2006-00356 - OD (RIGHT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 974953

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other