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PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target ...

FDA Device Recall #Z-0651-2017 — Class II — September 19, 2016

Recall Summary

Recall Number Z-0651-2017
Classification Class II — Moderate risk
Date Initiated September 19, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bausch & Lomb Inc Irb
Location Rochester, NY
Product Type Devices
Quantity 4,652,822 units

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.

Distribution Pattern

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

Lot / Code Information

Item #623815, UPC: 310119038154, Lot number: GE15012ST, Lot Exp. Date: 2016/11/30, Lot number: GF15055ST, Lot Exp. Date: 2016/12/31, Lot numbers: GH15053R, GH15056-1, GH15067ST, GH15070ST, GH15076ST, GH15081ST and GH15086-1, Lot Exp. Date: 2017/02/28, Lot numbers: GK15116ST, GK15118A1, Lot Exp. Date: 2017/04/30, Lot numbers: GL15148-1 and GL15148-2, Lot Exp. Date: 2017/05/31, Lot number: GC16080-1, Lot Exp. Date: 2017/09/30 and 623815C (3 oz.), Lot numbers: GE16060A1 and GE16066-1, Lot Exp. Date: 2017/11/30; Item #623816 (12oz.), UPC 310119038161, Lot numbers: GC15002ST, GC15008ST, GC15008ST1 and GC15012AST, Lot Exp Date: 2016/09/30, Lot numbers: GD15100ST1, GD15115AST, GD15124ST and GD15124ST2, Lot Exp Date: 2016/10/31, Lot numbers: GE15132ST and GE15156ST, Lot Exp Date: 2016/11/30, Lot numbers: GF15110ST and GF15110ST1, Lot Exp Date: 2016/12/31, Lot numbers: GG15023STR, GG15038ST and GG15044ST, Lot Exp Date: 2017/01/31, Lot numbers: GH15036ST, GH15039ST, GH15045ST and GH15128ST, Lot Exp Date: 2017/02/28, Lot numbers: GJ15070ST and GJ15081ST, Lot Exp Date: 2017/03/31, Lot numbers: GK15129ST and GK15131ST, Lot Exp Date: GL15004STR, GL15012ST and GL15048ST, Lot Exp Date: 2017/05/31, Lot numbers: GM15027AST, GM15034ST, GM15041ST and GM15044ST, Lot Exp Date: 2017/06/30, Lot numbers: GA16023ST1, GA16052ST and GA16056ST, Lot Exp Date: 2017/07/31, Lot numbers: GC16035ST, GC16044ST and GC16060ST, Lot Exp Date: 2017/09/30, Lot numbers: GE16001ST, GE16004ST, GE16009ST and GE16009ST1, Lot Exp Date: 2017/11/30, Lot numbers: GF16087ST and GF16087ST1, Lot Exp Date: 2017/12/31, Lot number: GG16003ST, Lot Exp Date: 2018/01/31 and 623816B, UPC 310119038161, Lot number: GG16116ST, Lot Exp Date: 2017/10/31; Item #623817 (12 oz. Twin Pack), UPC 310119038178, Lot number: GC15026ST, Lot Exp Date: 2016/09/30, Lot numbers: GD15095ST, Lot Exp Date: 2016/10/31, Lot numbers: GE15131ST, GE15133ST, GE15149ST and GE15161AST, Lot Exp Date: 2016/11/30, Lot number: GF15107ST1, Lot Exp Date: 2016/12/31, Lot numbers: GG15002STR and GG15037ST, Lot Exp Date: 2017/01/31, Lot numbers: GH15037ST, GH15038ST, GH15122ST and GH15132ST, Lot Exp Date: 2017/02/28, Lot numbers: GJ15078ST, GJ15094ST and GJ15104ST, Lot Exp Date: 2017/03/31, Lot numbers: GK15136ST, GK15142ST and GK15147ST, Lot Exp Date: 2017/04/30, Lot numbers: GL15046ST and GL15054ST, Lot Exp Date: 2017/05/31, Lot numbers: GM15037ST and GM15048ST, Lot Exp Date: 2017/06/30, Lot numbers: GA16027ST, GA16032ST, GA16036ST, GA16043ST, GA16046ST and GA16060ST, Lot Exp Date: 2017/07/31, Lot number: GC16049ST, Lot Exp Date: 2017/09/30, Lot numbers: GE16013ST, GE16014ST, GE16030ST and GE16033ST, Lot Exp Date: 2017/11/30 and Lot number: GF16083STR1, Lot Exp Date: 2017/12/31; Item #623908 (Target), UPC 310119039083, Lot number: GD15100ST, Lot Exp Date: 2016/10/31, Item #623910 (Walmart), UPC 310119039106, Lot numbers: GD15124ST1, Lot Exp Date: 2016/10/31. Lot number: GJ15084ST, Lot Exp Date: 2017/03/31; Item #629712 (Starter Kit), UPC 310119097120, Lot numbers: GC15037ST, GC15044ST, GC15044ST1, GC15049ST and GC15052ST Lot Exp. Date: 2016/09/30, Lot numbers: GD15133-1, GD15139ST and GD15144ST, Lot Exp. Date: 2016/10/31, Lot numbers: GE15016ST, GE15021ST and GE15028ST, Lot Exp. Date: 2016/11/30, Lot numbers: GF15006ST, GF15018ST, GF15050AST, GF15052ST, GF15060ST, GF15064ST, GF15071ST, GF15075-1 and GF15084ST, Lot Exp. Date: 2016/12/31, Lot numbers: GH15105ST, GH15107ST, GH15108ST, GH15109ST and GH15120ST, Lot Exp. Date: 2017/02/28, Lot numbers: GK15090ST, GK15092ST, GK15095ST, GK15100ST, GK15106ST and GK15118ST, Lot Exp. Date: 2017/04/30, Lot numbers: GL15160ST and GL15163ST, Lot Exp. Date: 2017/05/31, Lot numbers: GM15001ST, GM15005ST, GM15011-1 and GM15020-1, Lot Exp. Date: 2017/06/30, Lot numbers: GA16072-1 and GA16076-1, Lot Exp. Date: 2017/07/31, Lot number: GC16075-1, Lot Exp. Date: 2017/09/30 and Lot numbers: GE16048-1, GE16048-3, GE16052-1 and GE16057-1, Lot Exp. Date: 2017/11/30.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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