BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON

    MDR report key: 2614767 · Received June 7, 2012

    Report

    Report Number
    MW5025733
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ALCON, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE, A RESTOR 3D MULTIFOCAL IOL WAS INJECTED INTO THE CAPSULAR BAG. AS THE LENS UNFOLDED AN ATTEMPT TO ROTATE IT SO THE HAPTICS WERE VERTICAL WAS UNSUCCESSFUL. THE IOL WOULD NOT ROTATE AND WAS DISPLACED NASALLY. AFTER INSPECTION, IT WAS NOTED, THE HAPTIC WAS NOT STUCK TO THE OPTIC. FURTHER INSPECTION REVEALED WHAT APPEARED TO BE A LARGE RENT IN THE POSTERIOR CAPSULE NASALLY. VISCOAT WAS INJECTED OVER THE AREA OF THE PC RENT AND ABOVE THE IOL. MICRO FORCEPS AND SCISSORS WERE USED TO CUT THE IOL IN HALF AND IT WAS REMOVED FROM THE EYE. THE ANTERIOR CHAMBER WAS INTACT SO AN AMO Z9003, +22.00 D WAS INSERTED INTO THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON RESTOR MULTIFOCAL IOL HQL ALCON, INC. SN6AD1 21.5D

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention