BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-FLEX ASPHERIC

    MDR report key: 2210383 · Received August 8, 2011

    Report

    Report Number
    9611165-2011-00013
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 4, 2011
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD
    Product Code
    MSS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, (B)(4), IS NOT AVAILABLE FOR SALE IN THE UNITED STATES. EXAMINATION OF THE LENS MANUFACTURING RECORDS CONFIRM ROUTINE MANUFACTURE AND STERILIZATION. REVIEW OF THE COMPLAINT RECORDS CONFIRM THAT THERE IS NO ADVERSE TREND AND THAT THIS IS THE ONLY COMPLAINT AGAINST THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). THE PT UNDERWENT IMPLANTATION OF AN INTRAOCULAR LENS WITHOUT COMPLICATION. ONE WEEK AFTER IMPLANTATION THE PT REPORTED PAIN AND DEFECTIVE VISION. A LOCAL OPHTHALMOLOGIST EXAMINED AND FOUND HYPOPYON AND VITREOUS HAZE. THE PT WAS TREATED WITH TOPICAL ANTIBIOTIC, ANTIFUNGAL, STEROIDS, CYCLOPLEGICS, ANTI-GLAUCOMA MEDICATION, SYSTEMIC ANTIBIOTICS, ANTI-INFLAMMATORY AND ANTI-FUNGAL MEDICATION. THE PT THEN UNDERWENT A POSTERIOR VITRECTOMY AND WAS DISCHARGED 12 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX ASPHERIC INTRAOCULAR LENS MSS RAYNER INTRAOCULAR LENSES LTD 970C 027E7215554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention