BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 3919546 · Received June 10, 2014

    Report

    Report Number
    9611165-2014-00056
    Event Type
    Other
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 2, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LIMITED HAS ALLOCATED THE REF: (B)(4) TO THIS CASE. THE C-FLEX ASPHERIC 970C WAS LOADED BY THE SCRUB NURSE. THE HEALTHCARE FACILITY REPORTS THAT NO RESISTANCE WAS ENCOUNTERED DURING INJECTION. HAPTIC BREAKAGE WAS OBSERVED UPON IMPLANTATION OF THE IOL INTO THE EYE. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY IN THE ORIGINAL PLANNED SURGERY SESSION. THE C-FLEX ASPHERIC 970C IOL SUBJECT TO THIS REPORT WAS EXPLANTED. A BACK-UP IOL WAS IMPLANTED WITHOUT FURTHER COMPLICATION AND WITHOUT ANY ADVERSE EFFECT TO THE PT. THE INFO RECEIVED INDICATES THAT HAPTIC BREAKAGE MAY HAVE OCCURRED AS A RESULT OF A USER LOADING ERROR. A MEDICAL ACCUJECT INJECTOR WAS UTILISED TO IMPLANT THE C-FLEX ASPHERIC 970C IOL. THE INJECTOR WAS RETAINED AND RETURNED TO RAYNER. RAYNER HAS SENT THE ACCUJECT INJECTOR TO THE MANUFACTURER (MEDICEL AG) FOR INSPECTION. THE C-FLEX ASPHERIC 970C IOL WAD DISCARDED BY THE HEALTHCARE FACILITY FOLLOWING EXPLANTATION. NO DEVICE ANALYSIS CAN BE UNDERTAKEN BY RAYNER IN THIS INSTANCE. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX ASPHERIC 970C IOL BATCH 123E54282 SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM THIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A (B)(6) HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING IMPLANTATION OF A C-FLEX ASPHERIC 970C IOL. THE EVENT DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY STATES "LEADING HAPTIC WAS BROKEN WHEN LENS WAS PLACED INTO THE EYE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338255 C-FLEX ASPHERIC HQL: INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 970C 123E54282

    Patients

    Seq Age Sex Outcome Treatment
    1