BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLAB

    MDR report key: 146402 · Received January 2, 1998

    Report

    Report Number
    146402
    Event Type
    Injury
    Date Received
    January 2, 1998
    Date of Event
    August 12, 1997
    Report Date
    August 21, 1997
    Manufacturer
    CHIRON
    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

    IOL INSERTED 08/21/1992 LENS DISPLACED AND PT RETURNED TO SURGERY 08/12/1997 FOR REMOVAL/REPLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention