BEUDAMED
    FDA Recall Terminated

    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

    Recall: Z-2202-2013 · Initiated August 9, 2013

    Recall

    Recall Number
    Z-2202-2013
    Event Number
    66027
    Firm
    Sonogage Inc
    FEI Number
    1526843
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 9, 2013
    Posted
    September 16, 2013
    Terminated
    September 19, 2015
    Address
    26650 Renaissance Pkwy, Cleveland, OH, 44128-5776

    Description

    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

    Reason

    During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.

    Action

    Sonogage sent an Urgent: Medical Device Recall letter dated August 9, 2013 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine inventory and quarantine the affected product for return. Customers were asked to complete and return the enclosed response form. For question call 216-464-1119 or 800-798-1119.

    Distribution

    Worldwide Distribution - USA Nationwide in the following states: AK, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MN, NE, NJ, NM, NY, OH, OR, PA, TX, VA and WA. Product was also shipped to Canada and Mexico.

    Quantity

    564 units