BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO

    MDR report key: 2940910 · Received November 1, 2006

    Report

    Report Number
    2940910
    Event Type
    Injury
    Date Received
    November 1, 2006
    Date of Event
    October 27, 2006
    Report Date
    November 1, 2006
    Manufacturer
    AMO, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE INTRA-OCULAR LENS HAD TO BE REMOVED AND REPLACED. LENS BECAME CLOUDY AFTER INITIAL PLACEMENT ON (B)(6) 2006. MANUFACTURER WAS AWARE OF POTENTIAL PROBLEM AND HAD NOT RECALLED PRODUCT. IT ARRIVED IN THIS FACILITY FROM MANUFACTURER ON (B)(4) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO INTRA-OCULAR LENS HQL AMO, INC. SI40NB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention