BEUDAMED
    FDA Recall Terminated

    AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses

    Recall: Z-1557-2011 · Initiated February 21, 2011

    Recall

    Recall Number
    Z-1557-2011
    Event Number
    58008
    Firm
    Marietta Vision
    FEI Number
    1000140384
    Product Code
    LPN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2011
    Posted
    March 4, 2011
    Terminated
    November 3, 2011
    Address
    397 N Sessions St Nw, Marietta, GA, 30060-1325

    Description

    AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses

    Reason

    Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.

    Action

    John Patterson, President of Marietta Vision called each optical retailer on February 21, 2011, and told them of the misbranding issue in regards to country of origin. In addition, an Urgent Product Recall letter was sent to each account on February 23, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their AquaRefresh inventory for lot number KD005, and discontinue distribution of the samples immediately and to return any outstanding stock to Marietta Vision for exchange. Marietta Vision would return the misbranded product back to the Mexican factory at their expense to have the product packaging corrected. If they elect not to do so, Marietta Vision would have the product disposed of. Customers were instructed to fax the enclosed form back to Marietta Vision at 678-797-1099. For questions regarding this recall call 866-300-6257.

    Distribution

    Nationwide Distribution including AR, AZ, CA and TX.

    Quantity

    500/2 fl.oz. Bottles