BEUDAMED
    FDA Enforcement Class II Terminated

    C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification

    Recall: Z-3282-2018 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-3282-2018
    Event ID
    80943
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rayner Intraocular Lenses Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    October 10, 2018
    Initiation Date
    August 9, 2018
    Classification Date
    September 28, 2018
    Termination Date
    November 24, 2020
    Address
    The Ridley Innovation Centre, 10 Dominion Way, Worthing, N/A, United Kingdom

    Description

    C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification

    Reason

    Firm become aware of reports of post-operative refractive errors following implantation of lenses.

    Code Info

    Batch 017100825 Lens #'s: 01710082501, 01710082502, 01710082503, 01710082504, 01710082505, 01710082506, 01710082507, 01710082508, 01710082509, 01710082510, 01710082511, 01710082512, 01710082513, 01710082514, 01710082515, 01710082516, 01710082517, 01710082518, 01710082519, 01710082520, 01710082521, 01710082522, 01710082523, 01710082524, 01710082525, 01710082526, 01710082527, 01710082528, 01710082529, 01710082530, 01710082531, 01710082532, 01710082533, 01710082534, 01710082535, 01710082536, 01710082537, 01710082538, 01710082539, 01710082540, 01710082541, 01710082542, 01710082543, 01710082544, 01710082545, 01710082546, 01710082547, 01710082548, and 01710082549.

    Distribution

    US in the states of MO

    Quantity

    49