BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 781104 · Received November 10, 2006

    Report

    Report Number
    1119421-2006-00370
    Event Type
    Other
    Date Received
    November 10, 2006
    Date of Event
    January 1, 2006
    Report Date
    October 12, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H.3., 6.: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE REPORTER ON 10/20/2006. TO DATE, SHE HAS NOT RESPONDED.

    Description of Event or Problem · 1

    A PATIENT REPORTS THAT FOLLOWING RECENT BILATERAL INTRAOCULAR LENS IMPLANT SURGERIES, HE IS EXPERIENCING HALOS AND DOUBLE VISION. IT HAS BEEN APPROXIMATELY FOUR MONTHS SINCE THE SURGERIES AND HE CALLED TO REQUEST INFORMATION ON ADAPTATION FOLLOWING CATARACT SURGERY USING THIS LENS MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PATIENT TO ALLOW FURTHER FOLLOW-UP WITH THE IMPLANTING SURGEON. MDR #1119421-2006-00369--OD; MDR #1119421-2006-00370--OS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other