Recall Z-0651-2017— Bausch & Lomb Inc Irb
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb Inc Irb, initiated 2016-09-19, terminated 2018-08-28. It names one FDA 510(k) clearance: K132216. Product: 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..
- Recalling firm
- Bausch & Lomb Inc Irb
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-19
- Terminated
- 2018-08-28
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Product was found to contain excess residual levels of hydrogen peroxide.
Data sourced from openFDA. This site is unofficial and independent of the FDA.