BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON

    MDR report key: 6409127 · Received March 13, 2017

    Report

    Report Number
    MW5068465
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 1, 2017
    Manufacturer
    ALCON
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LENS IN THE PRE-LOADED DELIVERY SYSTEM WAS IMPLANTED AND SURGEON SAW THAT ONE OF THE HAPTICS DID NOT DEPLOY WITH THE LENS. SCRUB AND SURGEON FOUND THE HAPTIC STILL IN THE DELIVERY SYSTEM. SURGEON STATED THAT THE LENS PLACEMENT WAS EXACTLY WHERE IT NEEDED TO BE IMPLANTED AND LENS WITH 1 HAPTIC STAYED IMPLANTED. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: MATURE CATARACT LEFT EYE. "EVENT ABATED AFTER THE STOPPED OR DOSE REDUCED: NO. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182446 ALCON INTRAOCULAR LENS HQL ALCON 22.5D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other