Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1
Summary
The FDA issued a Class II for Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact by CooperVision, Inc.. Reason: a limited number of lots were manufactured with an incorrect cylinder power..
Details
Source
Device Recall
External ID
Z-1455-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Brand 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
Lot/Code Info: 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;
Quantity Affected: 33990 lenses (17010 US, 16980 OUS)
Reason for Recall
a limited number of lots were manufactured with an incorrect cylinder power.
Distribution
Domestic: 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-27
Company
West Henrietta, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 216 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperVision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperVision, Inc. have FDA actions?
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1455-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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