BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 1736259 · Received June 23, 2010

    Report

    Report Number
    9611165-2010-00008
    Event Type
    Injury
    Date Received
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PARENT LENS AND INJECTOR BATCH PROCESS RECORDS CONFIRM ROUTINE MANUFACTURE AND STERILIZATION. THERE IS NOTHING IN THE PRODUCTION RECORDS TO SUGGEST THAT EITHER THE LENS OR THE INJECTOR WERE DEFECTIVE. REVIEW OF COMPLAINT FILES INDICATE NO OTHER COMPLAINTS HAVE BEEN LODGED AGAINST THIS LOT NUMBER. NO PICTURES OF THE ALLEGEDLY DEFECTIVE LENS ARE AVAILABLE FOR REVIEW. THE SURGEON HAS STATED THAT HE INTENDS TO EXPLANT THE DEVICE DURING (B)(6) 2010. RAYNER IS ASSISTING THE SURGEON IN CONTACTING AN INDEPENDENT TEST LABORATORY WHICH CAN EXAMINE AND TEST THE LENS AFTER EXPLANTATION. THE RESULTS OF TESTING WILL BE REVIEWED, IF MADE AVAILABLE TO RAYNER BY THE SURGEON. THIS MODEL, 970C, IS NOT AVAILABLE IN THE USA. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED A DISTORTION ON THE ANTERIOR SURFACE OF THE LENS. HE INTERPRETED THIS AS A POTENTIAL ANTERIOR MEMBRANE AND ON THAT ASSUMPTION TRIED SEVERAL YAG SHOTS TO FIND THAT THIS WAS NOT THE CASE. THE CASE WAS FILED AS UNEXPLAINED. THE CASE WAS A DIABETIC RETINOPATHY, HAD COMBINED PHACO-VITRECTOMY PROCEDURES AND POSTERIOR INFLAMMATION AND HEMORRHAGE. THE FRONT PART OF THE LENS SEEMS AFFECTED AND THE REST SEEMS PERFECTLY TRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX ASPHERIC STANDARD ASPHERIC IOL HQL RAYNER INTRAOCULAR LENSES LTD. 970C 068E8093809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention