BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLAB

    MDR report key: 174503 · Received June 26, 1998

    Report

    Report Number
    174503
    Event Type
    Injury
    Date Received
    June 26, 1998
    Date of Event
    May 13, 1998
    Report Date
    May 15, 1998
    Manufacturer
    CHIRON VISION
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A RIGID THREE PIECE POSTERIOR CHAMBER INTRA OCULAR LENS INSERTED INTO THE CILIARY SULCUS OF THE RIGHT EYE ON 05/01/1998. TWO DAYS POST OPERATIVELY, SHE EXPERIENCED NAUSEA AND VOMITING WITH LOSS OF VISION IN THE RIGHT EYE. EXAMINATION REVEALED INFERIOR DISLOCATION. THEREFORE, THE PATIENT WAS RETURNED TO SURGERY ON 5/13/1998 FOR REMOVAL OF DISLOCATED LENS AND INSERTION OF AN ANTERIOR CHAMBER INTRA OCULAR LENS VIA PARTIAL MECHANICAL ANTERIOR VITRECTOMY. IOLAB MODEL U85JM, DIOPTER 17.0 INSERTED 05/13/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOLAB Implant IOL HQL CHIRON VISION 4346S *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention