BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX

    MDR report key: 4120855 · Received September 24, 2014

    Report

    Report Number
    3003563511-2014-00065
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    July 31, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    "FIVE PATIENTS (3 MALE, 2 FEMALE) WERE IDENTIFIED TO HAVE DEVELOPED IOL OPACIFICATION AFTER DSAEK SURGERY, WITH AVERAGE AGE OF 75.8 YEARS (RANGE 71-81). ALL PATIENTS UNDERWENT DSAEK FOR CORNEAL DECOMPENSATION SECONDARY TO FUCHS' ENDOTHELIAL DYSTROPHY AND HAVE RECEIVED HYDROPHILIC ACRYLIC IOL MODELS DURING THEIR PRIOR CATARACT SURGERY, INCLUDING 4 WITH SOFTEC 1 ((B)(4)) AND 1 WITH 570C ((B)(4)). ALL PATIENTS HAVE DEVELOPED A CENTRAL CRYSTALLINE OPACIFICATION ON THE ANTERIOR ASPECT OF THE IOL, OCCURRING BETWEEN 5 MONTHS AND UP TO 6 YEARS AFTER DSAEK SURGERY." (QUOTE SOURCE: INTRAOCULAR LENS OPACIFICATION AFTER DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY. AUTHORS: P. MORGAN-WARREN AND A. PATEL). FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595095 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 570C NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention