BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 3953325 · Received July 18, 2014

    Report

    Report Number
    3003563511-2014-00060
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAS HAD REPEAT BILATERAL OCULAR SURGICAL TRAUMA, WITH OCULAR INFLAMMATION OVER A PROLONGED TIME, THE COMBINATION OF ENVIRONMENTAL CONDITIONS, MULTIPLE SURGICAL PROCEDURES AND PT HEALTH COULD BE CAUSATIVE FACTORS TO THE DEVELOPMENT OF OPACIFICATION IN THIS INSTANCE. RAYNER'S 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 (B)(4) 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. FOR FURTHER INFO PLEASE REFER TO RAYNER INTRAOCULAR LENSES LIMITED'S MDR 9611165-2014-00060.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423670 C-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 970C 028E78932

    Patients

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