BEUDAMED
    FDA Recall Terminated

    Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).

    Recall: Z-1004-2011 · Initiated July 20, 2010

    Recall

    Recall Number
    Z-1004-2011
    Event Number
    56759
    Firm
    Optovue Inc.
    FEI Number
    3005950902
    Product Code
    NQQ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    July 20, 2010
    Posted
    February 1, 2011
    Terminated
    February 8, 2011
    Address
    45531 Northport Loop W, Fremont, CA, 94538-6417

    Description

    Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).

    Reason

    Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.

    Action

    Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.

    Distribution

    Nationwide

    Quantity

    22 devices in the US.