BEUDAMED
    FDA Recall Terminated

    Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.

    Recall: Z-2964-2011 · Initiated June 20, 2011

    Recall

    Recall Number
    Z-2964-2011
    Event Number
    59426
    Firm
    Haag-Streit USA Inc
    FEI Number
    1000136533
    Product Code
    HJB
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    June 20, 2011
    Posted
    August 9, 2011
    Terminated
    March 8, 2013
    Address
    3535 Kings Mills Rd, Mason, OH, 45040

    Description

    Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.

    Reason

    A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.

    Action

    Haag-Streit USA, Inc. sent an "Urgent Field Safety Notices" dated June 20, 2011 to all affected customers. The letter included a description of the affected product and problem. The firm instructed their customers to make sure all new and current templates are saved and upgrade to EyeSuite version i4.000. Customers are asked to complete and return the Software Update Verification Form. For additional information contact the Haag-Streit at (513) 398-3937.

    Distribution

    Nationwide (USA) Distribution.

    Quantity

    216