BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX

    MDR report key: 4036548 · Received August 6, 2014

    Report

    Report Number
    9611165-2014-00065
    Event Type
    Other
    Date Received
    August 6, 2014
    Report Date
    July 31, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED HAS ALLOCATED THE REFERENCE C14147 TO THIS CASE. "ALL PATIENTS DEVELOPED A CENTRAL CRYSTALLINE OPACIFICATION ON THE ANTERIOR ASPECT OF THE IOL, OCCURRING BETWEEN 5 MONTHS AND UP TO 6 YEARS AFTER DSAEK SURGERY. FOUR PATIENTS (80%) HAD REQUIRED RE-BUBBLING WITH INTRACAMERAL INJECTION OF AIR FOR PARTIAL DISLOCATION OF DONOR GRAFT TISSUE WITHIN THE FIRST POST-OPERATIVE WEEK. THE PATIENT WHO DID NOT REQUIRE RE-BUBBLING HAD EXPERIENCED AN INTRAOCULAR PRESSURE (IOP) SPIKE ON THE FIRST POST-OPERATIVE DAY WHICH REQUIRED MEDICAL INTERVENTION. ONE PATIENT IS CURRENTLY AWAITING IOL EXCHANGE, WHILST THE REMAINDER ARE UNDER CONSERVATIVE MANAGEMENT". NO SPECIFIC INFORMATION RELATING TO THE CORRECTIVE ACTION OR THE OUTCOME OF THE PATIENT WITH A C-FLEX 570C IOL HAS BEEN MADE AVAILABLE TO RAYNER AT THIS TIME. RAYNER BECAME AWARE OF THIS INCIDENT OF IOL OPACIFICATION FOLLOWING A LITERATURE REVIEW. THE AUTHORS OF THE PAPER CONCLUDE "REPEATED EXPOSURE TO INTRACAMERAL AIR IN THE POST-OPERATIVE PERIOD MAY BE A MAJOR AETIOLOGICAL FACTOR, ALTHOUGH RAISED IP AND OTHER FACTORS MAY ALSO CONTRIBUTE". A COPY OF THE PAPER CAN BE FOUND ENCLOSED. RAYNER HAVE CONTACTED THE PAPERS AUTHORS TO OBTAIN SPECIFIC INFORMATION PERTAINING TO THE DEVELOPMENT OF OPACIFICATION OF THE CFLEX 570C IOL AND THE SUBSEQUENT TREATMENT OF IOL OPACIFICATION.

    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 THE PRIOR CATARACT SURGERY, INCLUDING 4 WITH SOFTEC 1 (LENSTEC, UK, WAKEFIELD, UK) AND 1 WITH 570C (RAYNER INTRAOCULAR LENSES LTD, (B)(6)). 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459227 C-FLEX HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 570C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention