BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 211397 · Received February 19, 1999

    Report

    Report Number
    1119421-1999-00177
    Event Type
    Malfunction
    Date Received
    February 19, 1999
    Report Date
    January 20, 1999
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS A SCRATCH/MARK ON A LENS NOTED WHEN THE PACKAGE WAS OPENED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN