BEUDAMED
    FDA Recall Terminated

    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

    Recall: Z-1153-2014 · Initiated February 3, 2014

    Recall

    Recall Number
    Z-1153-2014
    Event Number
    67440
    Firm
    Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany
    FEI Number
    3001362763
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 3, 2014
    Posted
    March 7, 2014
    Terminated
    March 7, 2014

    Description

    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

    Reason

    Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.

    Action

    The firm, Zeiss, sent an "Important Field Safety Advisory Note" letter dated February 3, 2014 to its customer. Letter indicates that a phone call preceded the letter on January 23, 2014. The letter also describes the product, problem and actions to be taken. The customers were instructed to quarantine all treatment packs size "M", batch number M 130010; return the material to Carl Zeiss Meditec, Inc., 5160 Hacienda Dr, Dublin, CA 94568 and Zeiss will issue a credit for all material received, upon receipt of the returned materia, and to complete and return the Conformation Form with the envelop provided. If you have any questions regarding this field corrective action, please call 925-557-4832 or email at [email protected].

    Distribution

    US Distribution: NV only.

    Quantity

    1 package containing 10 individual treatment packs