Lens, Contact, (disposable)
Ophthalmic · 21 CFR 886.5925
Recent MDR events
372 adverse event reports on file
- FOCUS DAILIESJul 13, 2026InjuryAlcon Research, Llc1065835-2026-00010
- CLARITI 1 DAY (SOMOFILCON A)Jun 4, 2026InjuryCoopervision Cl Kft3009108089-2026-00001
- CLARITI 1 DAY (SOMOFILCON A)Jun 4, 2026InjuryCoopervision Cl Kft3009108089-2026-00002
- MYDAY TORIC (STENFILCON A)May 8, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00012
- MYDAY (STENFILCON A)May 8, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00014
- MYDAY TORIC (STENFILCON A)May 8, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00013
- DAILIES AQUACOMFORT PLUS MULTIFOCALApr 30, 2026InjuryAlcon Research, Llc1065835-2026-00005
- HUBBLEMar 30, 2026InjurySt. Shine Optical Co., Ltd.9617499-2026-00001
- MYDAY (STENFILCON A)Mar 13, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00009
- MYDAY TORIC (STENFILCON A)Feb 25, 2026InjuryCoopervision Manufacturing Puerto Rico, Llc2640128-2026-00005
Event type breakdown
Recalls
16 recall events for this product code
- CooperVision, Inc.Open, ClassifiedSep 19, 2025
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric.
One lot manufactured with an invalid sterilization cycle.
Z-2606-2025 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedSep 19, 2025
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables.
One lot manufactured with an invalid sterilization cycle.
Z-2607-2025 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedSep 19, 2025
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric.
One lot manufactured with an invalid sterilization cycle.
Z-2608-2025 · View FDA record ↗ - CooperVision, Inc.Open, ClassifiedMar 26, 2025
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DA
a limited number of lots were manufactured with an incorrect cylinder power.
Z-1455-2025 · View FDA record ↗ - Ontact IncOpen, ClassifiedJul 5, 2024
24K Premium Lense, Distributed by Updream Inc.
Contact lenses recalled due to potential bacterial contamination.
Z-2270-2024 · View FDA record ↗ - CooperVision Inc.TerminatedDec 19, 2013
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
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Z-0542-2014 · View FDA record ↗ - CooperVision Inc.TerminatedDec 19, 2013
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsvil
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Z-0543-2014 · View FDA record ↗ - Johnson & Johnson Vision Care, Inc.TerminatedJan 12, 2012
Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016
Johnson & Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton lot number and power are not the same as on the primary package inside the carton.
Z-0734-2012 · View FDA record ↗ - CooperVision Inc.TerminatedNov 9, 2009
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, an
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.
Z-0125-2010 · View FDA record ↗ - 1-800 Contacts Inc.TerminatedNov 3, 2004
Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatible
Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.
Z-0164-05 · View FDA record ↗
Registered firms
668 firms currently registered for this product code
Hoya Lamphun Ltd., Hoya Eye Care Thailand
Amphur Muang Lamphun, TH
Lm Global Enterprises Ltd.
Burnaby British Columbia, CA
Lens Global Limited
Chesham Buckinghamshire, GB
Visco Vision Inc.
Guishan Dist. Taoyuan, TW
Menicon Co. Ltd. Global Logistics Center
Yachiyo Chiba, JP
Objectt Optik Company Limited
HONG KONG, CN
Zumrut Lens Saglik Hizm. Ve Optik Ur. Dis. Tic. Ltd. Sti.
FATIH Istanbul, TR
Wisconsin Vision Associates Inc.
Burlington, WI, US
7051395 Canada Inc Dba Hta Direct Sourcing
Champlain, NY, US
Alcon Research, Llc
DULUTH, GA, US
Coopervision, Inc.
SCOTTSVILLE, NY, US
Ciba Vision Asian Manufacturing And Logistics Pte. Ltd.
SINGAPORE South West, SG
Tapaszto Optic Ltd.
Kecskemet Bacs-Kiskun, HU
Enlaces Corporativos 55 Del Norte S.a. De C.v.
MEXICO Ciudad de Mexico, MX
Bloom Max Limited
Central Hong Kong, CN
Optical Connection Technology Inc.
SAN DIEGO, CA, US
Pegavision Corporation
TAOYUAN, TW
Fine Vision Optical Company
Mumbai Maharashtra, IN
Kelabit S.r.o.
Ostrava Moravskoslezsky Kraj, CZ
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL, US
510(k) clearances
26 clearances for this product code
- HOYA Lamphun , Ltd.Jul 7, 2026
K261812 · HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
- Alcon Laboratories, Inc.Sep 22, 2020
K202448 · DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- Alcon Laboratories, Inc.Aug 21, 2020
K202036 · Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- Yung Sheng Optical Co., Ltd.Jun 15, 2015
K150630 · Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
- Yung Sheng Optical Co., Ltd.Jan 16, 2015
K143190 · Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
- Sauflon Pharmaceuticals, Ltd.Jul 26, 2013
K130331 · SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
- Bausch & Lomb, Inc.Oct 25, 2011
K112192 · NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
- Clearlab SG Pte, Ltd.Oct 15, 2008
K080632 · CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS