BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 787133 · Received June 9, 2006

    Report

    Report Number
    1119421-2006-00151
    Event Type
    Other
    Date Received
    June 9, 2006
    Report Date
    May 11, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS IMPLANT SURGERY, SHE IS UNHAPPY WITH HER NEAR VISION. SHE REPORTS THAT SHE FEELS SHE SHOULD NOT HAVE TO WEAR READING GLASSES FOLLOWING SURGERY. FOLLOW-UP WITH THE SURGEON INDICATES THE PATIENT WAS FULLY INFORMED THAT CORRECTION MAY BE NEEDED FOLLOWING SURGERY. MFR. REPORT # 1119421-2006-00150--1ST EYE (OD). MFR. REPORT # 1119421-2006-00151--2ND EYE (OS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SA60D3 896782

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other