BEUDAMED
    FDA Adverse Event Summary report: N

    SN60WF INTRAOCULAR LENS

    MDR report key: 2010326 · Received February 24, 2011

    Report

    Report Number
    2010326
    Date Received
    February 24, 2011
    Date of Event
    May 18, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF ALCON SN60WF INTRAOCULAR LENS, THE TRAILING HAPTIC OF THE INTRAOCULAR LENS BROKE INTRAOCULARLY. THIS WAS SUCESSFULLY RETRIEVED AND THE ENTIRE LENS CUT AND ROTATED OUT OF THE EYE SAFELY. SUBSEQUENTLY, A REPLACEMENT SN60WF INTRAOCULAR LENS WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SN60WF INTRAOCULAR LENS INTRAOCULAR LENS HQL ALCON LABORATORIES SN60WF *

    Patients

    Seq Age Sex Outcome Treatment
    1 *