BEUDAMED
    FDA Enforcement Class II Terminated

    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

    Recall: Z-0811-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0811-2014
    Event ID
    64966
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ziemer Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    April 16, 2013
    Classification Date
    January 23, 2014
    Termination Date
    December 27, 2017
    Address
    620 East Third Street, Alton, IL, 62002, United States

    Description

    1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.

    Reason

    A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.

    Code Info

    Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817

    Distribution

    Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.

    Quantity

    5 units