BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMO PHACO FLEX II INSERTION SYSTEM

    MDR report key: 114694 · Received June 20, 1997

    Report

    Report Number
    114694
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    March 5, 1997
    Report Date
    March 13, 1997
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    MSS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INSERTION DIFFICULTIES CAUSED BY SCRUB TECHNICIAN POSSIBLY LOADING INSERTER IMPROPERLY. HAPTIC DETACHED WHILE LENS WAS BEING INSERTED. LENS REMOVED AND NEW LENS INSERTED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMO PHACO FLEX II INSERTION SYSTEM SOFT IMPLANT LENS INSERTION DEVICE MSS ALLERGAN MEDICAL OPTICS PSHST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention