Atlas FDA

MVN

26 FDA 510(k) clearances · Product code

72 daysmedian time to decision
178 days90th percentile
26clearances measured

FDA profile

Official device name
Lens, Contact, (Disposable)
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5925
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 24 · 2022: 18 · 2023: 24 · 2024: 25 · 2025: 22 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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 (K261812)HOYA Lamphun , Ltd.2026-07-07
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448)Alcon Laboratories, Inc.2020-09-22
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036)Alcon Laboratories, Inc.2020-08-21
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 (K150630)Yung Sheng Optical Co., Ltd.2015-06-15
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190)Yung Sheng Optical Co., Ltd.2015-01-16
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331)Sauflon Pharmaceuticals, Ltd.2013-07-26
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192)Bausch & Lomb, Inc.2011-10-25
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632)Clearlab SG Pte, Ltd.2008-10-15
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755)Bausch & Lomb, Inc.2008-06-10
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K073060)Innova Vision, Inc.2007-11-29
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948)CooperVision, Inc.2006-11-22
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K061157)Bausch & Lomb2006-06-22
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832)Sauflon Pharmaceuticals, Ltd.2006-05-15
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS (K053191)Innova Vision, Inc.2006-05-12
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR (K051900)Johnson & Johnson Vision Care, Inc.2005-08-12
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (K050065)Ciba Vision Corporation2005-05-27
FRESHLOOK ONE-DAY COLOR CONTACT LENS (K050213)Ciba Vision Corporation2005-03-28
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES (K033701)Ciba Vision Corporation2003-12-15
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K020389)Ocular Sciences2002-06-04
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT (K011718)Bausch & Lomb, Inc.2001-07-25
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT (K010636)Ciba Vision Corporation2001-03-23
FOCUS DAILIES PROGRESSIVES (K003826)Ciba Vision Corporation2001-03-08
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES (K003586)Ciba-Geigy Corp.2001-02-08
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP (K993252)CooperVision, Inc.1999-11-24
DAILIES (NELFILCON A) ONE-DAY (K992446)Ciba Vision Johns Creek Mfg.1999-08-18
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS (K984273)Ciba Vision Corporation1999-01-25

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Every clearance here is in the API, with alerts when new ones post.