BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX

    MDR report key: 3597634 · Received November 26, 2013

    Report

    Report Number
    9611165-2013-00112
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    June 11, 2013
    Report Date
    November 12, 2013
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER INTRAOCULAR LENSES LIMITED. REMEDIAL, CORRECTIVE AND PREVENTIVE ACTION WAS TAKEN BY THE HEALTHCARE FACILITY IN THE ORIGINAL PLANNED SURGERY SESSION. THE C-FLEX 570C IOL WAS EXPLANTED FROM THE EYE AND EXCHANGED FOR A BACK-UP LENS OF THE SAME MODEL AND POWER. THE HEALTHCARE FACILITY REPORTS THAT THE ORIGINAL INCISION SIZE OF 2.65MM WAS ENLARGED TO 2.75MM TO AID EXPLANATION AND HAS STARTED THAT NO SUTURE WAS NECESSARY. THE HEALTHCARE FACILITY HAS REPORTED THAT THERE WAS SLIGHT BLEEDING AS A RESULT OF LENS EXPLANATION WHICH WAS IRRIGATED WITH BALANCED SALT SOLUTION. INITIAL POST-OP, THE PATIENT PRESENTED WITH SLIGHT HYPHEMA AND CYSTOID MACULAR EDEMA (CME). OUR REVIEW OF PRODUCTION RECORDS FOR THE C-FLEX 570C IOL BATCH (B)(4) SHOWED THAT ALL MANUFACTURING AND QUALITY CHECKS WERE CONDUCTED WITH SUCCESSFUL RESULTS. ALL LENSES RELEASED FOR DISTRIBUTION FROM HIS BATCH WERE WITHIN TOLERANCE, MET SPECIFICATION CRITERIA AND WERE WITHOUT DEFECTS. A REVIEW OF EXISTING VIGILANCE DATA FROM THE MONTH OF MANUFACTURE OF THE C-FLEX 570C IOL (JULY 2010) WAS CONDUCTED IN ORDER TO DETERMINE IF ANY TRENDS EXISTED. THIS REVIEW CONCLUDED THAT NO OTHER INCIDENTS, OF ANY TYPE HAVE BEEN RECEIVED AGAINST THE C-FLEX 570C IOL BATCH (B)(4). WITHOUT THE ABILITY TO EXAMINE THE DEVICE, A FAILURE MODE AND ROOT CAUSE CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A C-FLEX 570C INTRAOCULAR LENS (IOL). THE EVENT DESCRIPTION PROVIDED STATES THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617171 C-FLEX HQL RAYNER INTRAOCULAR LENSES LTD. 570C 070E13085

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR