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U.S. Department of Health and Human Services

Class 2 Device Recall Biotrue ONEday (nesofilcon A) lenses

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  Class 2 Device Recall Biotrue ONEday (nesofilcon A) lenses see related information
Date Initiated by Firm September 03, 2015
Date Posted November 04, 2015
Recall Status1 Terminated 3 on June 06, 2016
Recall Number Z-0206-2016
Recall Event ID 72161
510(K)Number K113703  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
Code Information Select -2.25/-3.00 Diopter Lot Numbers: W57209820 (exp. date 05/19/2019), W57210174 (exp. date 05/23/2019), W57210440 (exp. date 05/28/2019), W57211652 (exp. date 06/09/2019), W57211916 (exp. date 06/09/2019), W57212210 (exp. date 06/09/2019), W57212440 (exp. date 06/09/2019),  W57212697 (exp. date 06/09/2019), W57212926 (exp. date 06/09/2019), W57213158 (exp. date 06/09/2019), W57213453 (exp. date 06/09/2019), W57213743 (exp. date 07/01/2019), W57213969 (exp. date 07/01/2019), W57214208 (exp. date 07/01/2019), W57214459 (exp. date 07/01/2019),  W57214717 (exp. date 07/01/2019), W57215039 (exp. date 07/01/2019), W57215293 (exp. date 07/01/2019), W57215517 (exp. date 07/01/2019), W57215783 (exp. date 07/01/2019).
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc Irb
1400 Goodman St N
Rochester NY 14609-3547
For Additional Information Contact John D. Boselli
585-338-8169
Manufacturer Reason
for Recall		 The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
FDA Determined
Cause 2		 Process control
Action On 9/3/2015, the distributors received the Medical Device Recall Letter (dated 9/2/2015) via e-mail. Medical Device Recall Letters (dated 9/2/2015) and Customer Acknowledgement Cards were hand delivered to the direct customers via Bausch + Lomb Sales Representatives starting on 9/14/2015 or sent via FedEx if consignee is not a B+L account. The letter informs the accounts of the recall and instructs them to direct any consumers who would like to report a product complaint, arrange for a product exchange, or obtain more information on the product recall to contact the Bausch + Lombs Consumer Affairs Team at 1-800-553-5340 or via e-mail at BLCustomerCare@bausch.com. Customers may also contact Bausch + Lomb Customer Service at 1-800-828-9030 to arrange return of affected product.
Quantity in Commerce Domestic: 99,260 lenses; Foreign: 84,660 lenses
Distribution Distributed US (nationwide), Canada, Japan and Thailand.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LPL and Original Applicant = BAUSCH & LOMB INCORPORATED
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