Recall Z-0651-2017 ยท LPN Accessories, Soft Lens Products
Bausch & Lomb Inc Irb
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) con
| Date | Sep 19, 2016 |
| Status | Terminated |
| Reason | Product was found to contain excess residual levels of hydrogen peroxide. |
| Root cause | Under Investigation by firm |
| 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: |
| Quantity | 4,652,822 units |
| Distribution | Worldwide Distribution-U.S. Nationwide and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION Bausch & Lomb, Incorporated, Sep 9, 2013 |