BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO VITRAX SOLUTION

    MDR report key: 580037 · Received March 7, 2005

    Report

    Report Number
    2020664-2005-00002
    Event Type
    Injury
    Date Received
    March 7, 2005
    Date of Event
    November 4, 2004
    Report Date
    February 8, 2005
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    LZX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE VISCOELASTIC WAS BEING INJECTED INTO THE ANTERIOR CHAMBER, THE CANNULA CAME LOOSE FROM THE SYRINGE AND SPEARED INTO THE CATARACT. THE CATARACT WAS PUSHED POSTERIORLY BREAKING SOME OF THE ZONULE ATTACHMENTS. THE CANNULA WAS RETRIEVED AND THE PT REFERRED TO A RETINAL SPECIALIST TO COMPLETE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO VITRAX SOLUTION VISCOELASTIC LZX ADVANCED MEDICAL OPTICS VT265W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention