BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN MEDICAL OPTICS

    MDR report key: 189768 · Received September 29, 1998

    Report

    Report Number
    MW1014653
    Event Type
    Injury
    Date Received
    September 29, 1998
    Date of Event
    August 20, 1998
    Report Date
    September 11, 1998
    Manufacturer
    ALLERGAN, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATES THAT "IMPLANT WAS DEFECTIVE." INTRAOCULAR LENS WAS LOADED AND RELEASED INTO RIGHT EYE IN THE CAPSULAR BAG. SURGEON NOTED THAT THE ENTERING HAPTIC FELL OUT OF THE OPTIC AND THE TRAILING OPTIC DID NOT LEAVE THE INSERTER. FORCEPS WERE USED TO REMOVE THE HAPTIC WHICH HAD NEVER BEEN RELEASED INTO THE BAG. A RENT WAS NOTED IN THE APPROX. 3 O'CLOCK POSITION IN THE POSTERIOR CAPSULE REQUIRING AN ANTERIOR VITRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN MEDICAL OPTICS Implant INTRAOCULAR LENS HQL ALLERGAN, INC. S130NB *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention