BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 6272681 · Received January 24, 2017

    Report

    Report Number
    6272681
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 11, 2017
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LENS COMES PRELOADED TO AVOID ANY HUMAN TOUCH AND PREVENT SCRATCHES ON THE LENS SURFACE. IT IS SUPPOSED TO FOLD IN A WAY THAT FACILITATES INSERTION. THE FRONT HAPTIC WAS BENT TO THE RIGHT SIDE, BUT SHOULD HAVE BEEN FOLDED TO THE LEFT SIDE. I HAD TO STOP INSERTION AND MANUALLY REPOSITION THE HAPTIC PROPERLY IN THE BAG. THERE WAS NO RISK OR DANGER TO THE PATIENT BUT THE PRELOADED IMPLANT IS SUPPOSED TO MAKE INSERTION EASIER. IN THIS CASE IT DID NOT FULFILL ITS PURPOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55925 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. AU00T0

    Patients

    Seq Age Sex Outcome Treatment
    1