BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 117908 · Received September 5, 1997

    Report

    Report Number
    1119421-1997-00090
    Event Type
    Injury
    Date Received
    September 5, 1997
    Report Date
    December 16, 1996
    Manufacturer
    ALCON LABORATORIE, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS HAPTIC BROKE WHILE UNFOLDING IN THE EYE. THE WOUND WAS WIDENED TO REMOVE THE LENS AND THE LENS WAS THEN DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention