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U.S. Department of Health and Human Services

Class 2 Device Recall MyDay Toric

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 Class 2 Device Recall MyDay Toricsee related information
Date Initiated by FirmFebruary 27, 2025
Date PostedMarch 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1455-2025
Recall Event ID 96396
510(K)NumberK131378 K190965 K220070 
Product Classification Lens, contact, (disposable) - Product Code MVN
ProductBrand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No
Code Information Blister Lot Numbers: (1) 6461501582, (2) 6461501590, (3) 6448502235, (4) 6472500679. Carton Lot numbers: (1) 19346502595028, (2a) 344446500117, (2b) 19346502613, (2c) 21455502575, (3a) 21476504025, (3b) 21545502813, (3c) 24127502235, (3d) 40702500019, (4a) 21512501331, (4b) 21492501653, (4c) 21492501685;
Recalling Firm/
Manufacturer		 CooperVision, Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information ContactAnnette Nelson
1-925-6604471
Manufacturer Reason
for Recall		a limited number of lots were manufactured with an incorrect cylinder power.
FDA Determined
Cause 2		Process control
ActionOn February 27, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to direct consignees. We request you take the following actions: 1. Please examine your inventory/product shelf for any of the provided affected lot numbers. The lot number can be found on the back panel of the carton below the expiration date. (Carton lots 19346502595028, 19346502613028, 21545502813013, and 21512501331524) 2. While trials lenses are not impacted by this action, if your patients have discarded the carton, the affected product can be identified by examining the lot number printed on the blister. This number is different from the carton lot number. (Blister lots 6461501582, 6461501590, 6448502235, 6472500679) The lot number can be found on the front of the blister label below the expiration date. Below is an example and where to locate the lot number on both a carton and blister. Stop any further distribution of product from the designated lot numbers; 3. We recommend authorized distributors contact your accounts and Eye Care Practitioners contact your patients who have received the affected product with the enclosed draft Consumer Communication Letter, to be completed by the Eye Care Practitioner s office. 4. Please instruct any patients to return any affected product to their Eye Care Practitioner for replacement or credit. 5. Within the next five (5) business days, please complete the attached Correction Response Form and fax it to 888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; 6. Dispose of the affected product in your inventory or that is returned to you. 7. Your account will be credited once the form is received. 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting Program, either online, by regular mail, or by fax. 9. If your patients have questions or complaints, please have them contact our cu
Quantity in Commerce33990 lenses (17010 US, 16980 OUS)
DistributionDomestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA. International: Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MVN
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