BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 205543 · Received January 7, 1999

    Report

    Report Number
    1119421-1999-00026
    Event Type
    Other
    Date Received
    January 7, 1999
    Report Date
    December 9, 1998
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTS THAT SHE IS EXPERIENCING GLARE AND PAIN. PHYSICIAN STATES HE SEES NOTHING WRONG WITH THE INTRAOCULAR LENS. THE PT WILL BE SEEING ANOTHER PHYSICIAN FOR A SECOND OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA30BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other