BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 818543 · Received January 18, 2007

    Report

    Report Number
    1119421-2007-00013
    Event Type
    Other
    Date Received
    January 18, 2007
    Date of Event
    October 1, 2006
    Report Date
    December 19, 2006
    Manufacturer
    ALCON LABORATORIES, INC/HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO SIMILAR REPORTS IN THE LOT.

    Description of Event or Problem · 1

    SURGEON STATED A PT REPORTED DIFFICULTY SEEING BOTH NEAR AND FAR DISTANCES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE REPORTED THAT SHE CAN SEE BEST AT APPROX 50CM DISTANCE. SHE ALSO REPORTED SHE CANNOT DRIVE AT NIGHT DUE TO SEEING HALOS AROUND THE LIGHTS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTON SA60D3 826903

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other