BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAAR IOL

    MDR report key: 530195 · Received June 1, 2004

    Report

    Report Number
    MW1032248
    Event Type
    Injury
    Date Received
    June 1, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 1, 2004
    Manufacturer
    STAAR SURGICAL AG
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TRAILING EDGE OF PLATE HAPTIC WAS NOTED TO BE TORN AFTER INJECTION OF THE INTRAOCULAR LENS INTO THE EYE FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL. WOUND WAS ENLARGED, AND LENS REPLACED AS THERE WAS CONCERN FOR STABILITY OF THE LENS DUE TO THE NATURE OF THE TEAR. LENS WAS 23.5 DIOPTERS, NOT PARTICULARLY THICK OR THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAAR IOL FOLDABLE INTRAOCULAR LENS HQL STAAR SURGICAL AG CC4204BF *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention