Class 3 Device Recall ClearSight 1Day Toric

• Date Initiated by Firm: August 28, 2009
• Date Posted: November 09, 2009
• Recall Status: Terminated on June 12, 2012
• Recall Number: Z-0125-2010
• Recall Event ID: 53532
• Product Classification: Disposable Contact Lens - Product Code MVN
• Product: ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
• Code Information: Lot numbers: 446450034703 (Power -0075075090), 446850021203 (Power -0075125090), 446450034904 (Power -0100075090), 446450031005 (Power -0125075090), 446450030905 (Power -0125075090), 46450031105 (Power -0125075090), 446850024806 (Power -0150125090), 447050023406 (Power -0150125180), 447050022408 (Power -0200125180), 446450031509 (Power -0225075090), 447050024509 (Power -0225125180), 446650019310 (Power -0250075180), 446650020510 (Power -0250075180), 447050022510 (Power -0250125180), 446650019411(Power -0275075180), 446650020611(Power -0275075180), 446650019512 (Power -0300075180), 447050022812(Power -0300125180), 447050022912 (Power -0300125180), 447050022712 (Power -0300125180), 446650019914 (Power -0350075180), 446650021314 (Power -0375075180), 446650019616 (Power -0400075180), 446650020816 (Power -0400075180), 447050023016 (Power -0400125180), 446650020017(Power -0425075180), 447050023117 (Power -0425125180), 447050023218(Power -0450125180), 447050024118 (Power -0450125180), 447050024718 (Power -0450125180), 446650020119 (Power -0475075180), 447050023319(Power -0475125180), 447050024219 (Power -0475125180), 447050021022(Power -0550125180), 447050021122 (Power -0550125180), 447050023522(Power -0550125180), 447050023624 (Power -0600125180), and 446650016926(Power -0650075180).
• FEI Number: 3005724763
• Recalling Firm/ Manufacturer: CooperVision Inc.; 180 Thruway Park Dr; W Henrietta NY 14586-9798
• For Additional Information Contact: Ms. Bonnie Tsymbal; 800-341-2020 Ext. 3210
• Manufacturer Reason for Recall: Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA.
• FDA Determined Cause: Other
• Action: Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.
• Quantity in Commerce: 1440 cartons
• Distribution: Nationwide Distribution
• 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.