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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch Lomb PeroxiClear Peroxide Solution

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 Class 2 Device Recall Bausch Lomb PeroxiClear Peroxide Solutionsee related information
Date Initiated by FirmSeptember 19, 2016
Create DateNovember 21, 2016
Recall Status1 Terminated 3 on August 28, 2018
Recall NumberZ-0651-2017
Recall Event ID 75324
510(K)NumberK132216 
Product Classification Accessories, soft lens products - Product Code LPN
ProductPeroxiClear 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.
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. 
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc Irb
1400 Goodman St N
Rochester NY 14609-3547
For Additional Information ContactRobert Koger
864-338-6000
Manufacturer Reason
for Recall		Product was found to contain excess residual levels of hydrogen peroxide.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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: BauschandLomb5833@Stericycle.com 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.
Quantity in Commerce4,652,822 units
DistributionWorldwide Distribution-U.S. Nationwide and country of: Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPN
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