BEUDAMED
    FDA Recall Terminated

    Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)

    Recall: Z-1252-2016 · Initiated February 22, 2016

    Recall

    Recall Number
    Z-1252-2016
    Event Number
    73386
    Firm
    Innovative Ophthalmic Products, Inc
    FEI Number
    2083993
    Product Code
    KYF
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 22, 2016
    Terminated
    September 16, 2016
    Address
    3184 Airway Ave, Ste B, Costa Mesa, CA, 92626-4619

    Description

    Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)

    Reason

    Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.

    Action

    Innovative Ophthalmic Products, Inc ( IOP ) sent an Customer Notification letter dated February 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken. The letter informs the customers that IOP is recalling because the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement. Specifically, the new IFU caution statement is "Caution should be taken with supra-Tenon implantation of this device as erosion of the conjunctiva is known to result from the raised edge of the oval pressure ridge." For further questions please call (202) 857-6464

    Distribution

    Nationwide Distribution

    Quantity

    278 units