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.
FDA Recall Z-0651-2017 · Posted None
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Recalling FirmBausch & Lomb Inc Irb
Recall StatusTerminated
Product CodeLPN
Date Initiated2016-09-19
Date Terminated2018-08-28
Product Quantity4,652,822 units
Reason for Recall
Product was found to contain excess residual levels of hydrogen peroxide.
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: [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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution-U.S. Nationwide and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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