BEUDAMED
    FDA Recall Terminated

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    Recall: Z-0651-2017 · Initiated September 19, 2016

    Recall

    Recall Number
    Z-0651-2017
    Event Number
    75324
    Firm
    Bausch & Lomb Inc Irb
    FEI Number
    1317628
    Product Code
    LPN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 19, 2016
    Terminated
    August 28, 2018
    Address
    1400 Goodman St N, Rochester, NY, 14609-3547

    Description

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    Reason

    Product was found to contain excess residual levels of hydrogen peroxide.

    Action

    The firm, Bausch & Lomb, sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated 9/29/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter: review your inventory including floor displays; contact Stericycle, the firm conducting the product recall on behalf of Bausch & Lomb, to arrange for return of the product; and complete and return the Recall Acknowledgement Form to Stericycle Inc,, even if you do not have any of the product in your inventory, via Fax to 1-877-779-7814, email: [email protected] or phone: 1-877-877-0481. If you have any questions about this voluntary recall process or would like additional information, please contact Stericycle, Inc., the firm conducting the recall on behalf of Bausch & Lomb at 1-877-877-0481.

    Distribution

    Worldwide Distribution-U.S. Nationwide and country of: Canada.

    Quantity

    4,652,822 units