BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 3978795 · Received July 8, 2014

    Report

    Report Number
    9611165-2014-00060
    Event Type
    Other
    Date Received
    July 8, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER INTRAOCULAR LENSES LTD. HAS ALLOCATED THE REFERENCE (B)(4) TO THIS CASE. THE PATIENT HAS UNDERGONE MULTIPLE OCULAR PROCEDURES BOTH PRE AND POST C-FLEX ASPHERIC 970C IOL IMPLANTATION. THE HEALTHCARE PROFESSIONAL REPORTS THAT THE DEVELOPMENT OF OPACIFICATION WAS FIRST OBSERVED ON (B)(4) 2014. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY ON (B)(4) 2014. THE C-FLEX ASPHERIC 970C IOL WAS RETURNED TO RAYNER ON JULY 7TH 2014. ANALYSIS OF THE IOL WILL BE UNDERTAKEN BY A THIRD PARTY INDEPENDENT LABORATORY. THE RESULTS OF THE DEVICE ANALYSIS WILL BE PROVIDED IN A FOLLOW UP REPORT. THE PATIENT HAS HAD REPEAT BILATERAL OCULAR SURGICAL TRAUMA, WITH OCULAR INFLAMMATION OVER A PROLONGED TIME. THE COMBINATION OF ENVIRONMENTAL CONDITIONS, MULTIPLE SURGICAL PROCEDURES AND PATIENT HEALTH COULD BE CAUSATIVE FACTORS TO THE DEVELOPMENT OF OPACIFICATION IN THIS INSTANCE. OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX ASPHERIC 970C IOL BATCH 028E78932 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 ITS DISTRIBUTOR IN TAIWAN OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A C-FLEX ASPHERIC 970C INTRAOCULAR LENS (IOL). ON (B)(6) 2014 THE HEALTHCARE PROFESSIONAL OBSERVED THE DEVELOPMENT OF OPACIFICATIONS IN THE OS EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398516 C-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LTD. 970C 028E78932

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention TEAR-NATURALE| 1% PILOCARPINE| TIMOLOL-XE| SULFAMETHOXAZOLE| NEOSTIGMINE FLAROMETHOLINE