Class 2 Device Recall Proclear

• Date Initiated by Firm: November 20, 2013
• Date Posted: December 19, 2013
• Recall Status: Terminated on July 22, 2015
• Recall Number: Z-0542-2014
• Recall Event ID: 66844
• 510(K)Number: K061948
• Product Classification: Lens, contact, (disposable) - Product Code MVN
• Product: Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA; ; daily use disposable contact lenses
• Code Information: Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017; Lot 361950608721, potential incorrect expiry date 6/2018; Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018; Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potential incorrect expiry date 3/2017; Lot 361950863106, potential incorrect expiry date 9/2017; Lot 361950894913, potential incorrect expiry date 1/2018; Lot 361950912828, potential incorrect expiry date 6/2018; Lot 361950919611, potential incorrect expiry date 4/2018; Lot 361950919914, potential incorrect expiry date 4/2018; Lot 361950937619, potential incorrect expiry date 5/2018; Lot 361950955510, potential incorrect expiry date 7/2013, 8/2018; Lot 361950955610, potential incorrect expiry date 3/2018; Lot 361950971611, potential incorrect expiry date 4/2018; Lot 361950972311, potential incorrect expiry date 8/2018, 8/2013; Lot 361951007612, potential incorrect expiry date 7/2017; Lot 361951028930, potential incorrect expiry date 2/2018; Lot 361951041224, potential incorrect expiry date 2/2018; Lot 361951053705, potential incorrect expiry date 7/2018; Lot 361951057108, potential incorrect expiry date 7/2018.
• Recalling Firm/ Manufacturer: CooperVision Inc.; 180 Thruway Park Dr; W Henrietta NY 14586-9798
• For Additional Information Contact: Rebecca Leape; 800-341-2020
• Manufacturer Reason for Recall: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
• FDA Determined Cause: Incorrect or no expiration date
• Action: CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.
• Quantity in Commerce: 153 cartons
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
• 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 = MVN and Original Applicant = COOPERVISION, INC.