BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON

    MDR report key: 1061341 · Received June 16, 2008

    Report

    Report Number
    MW5007314
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ALCON
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SENILE CATARACT IN THE LEFT EYE WAS BEING TREATED. AN ALCON SN60WF 21.0 DIOPTER LENS -WAS INSERTED INTO THE LENS CAPSULE. AFTER THE LENS WAS INJECTED, THERE WAS NOTED TO BE A CRACK IN ONE OF THE HAPTICS WHICH POSITIONED THE LENS. THIS CRACK PREVENTED THE CENTRATION OF THE LENS. THEREFORE, IT WAS NECESSARY TO REMOVE THE LENS AND REPLACE IT WITH A SIMILAR LENS. DURING THE REMOVAL PROCESS, THE CRACKED HAPTIC BROKE OFF AND WAS RETRIEVED. THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY. DATE OF USE: 2008. DIAGNOSIS OR REASON FOR USE: SENILE LEFT CATARACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON INTRAOCULAR LENS HQL ALCON SN60WF 21.0 D

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR