BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 2241097 · Received August 16, 2011

    Report

    Report Number
    9611165-2011-00017
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MFG RECORDS FOR IOL AND INJECTOR DID NOT SHOW ANY ISSUES OR CONCESSIONS NOTED AGAINST THE C-FLEX ASPHERIC 970C LENS OR THE RAYNER R-INJ-04 SINGLE USE SOFT TIPPED INJECTOR. RAYNER HAS NOT RECEIVED ANY OTHER COMPLAINTS AGAINST THE LENS LOT NUMBER 041E21632 OR THE INJECTOR LOT NUMBER B148. THE C-FLEX ASPHERIC 970C LENS IS NOT AVAILABLE IN THE UNITED STATES OF AMERICA. (B)(4).

    Description of Event or Problem · 1

    RAYNER HAS RECEIVED AN INITIAL CONTACT FROM MR (B)(6). HE COMMENTS THAT "ALL LENSES WERE LOADED BY A THEATRE SISTER WITH 25 YEARS OF EXPERIENCE AS AN OPHTHALMIC THEATRE NURSE, BUT ONLY ABOUT 2 YEARS (MAXIMUM) EXPERIENCE OF LOADING IOLS. CASE WITH AMPUTATED HAPTIC: IOL EXPLANTED A SECOND IOL IMPLANTED NORMALLY. DELAY WAS LESS THAN 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX ASPHERIC INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 970C 041E21632

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention