Chrysalis Intelligence · Sponsors · CooperVision, Inc.

CooperVision, Inc.

San Ramon, CA, US · 5 510(k) clearances · 153 PMAs · 26 recalls

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Total clearances
5
2020-03-23 → 2024-01-25
Last 12 months
0
Product codes
1
Most recent
2024-01-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LPL Lenses, Soft Contact, Daily Wear Class II Ophthalmic 5 2024-01-25
Class III

PMA approvals (153)

Total PMA records
153
Originals + supplements
Distinct product codes
4
First decision
2020-01-10
Most recent
2026-07-07
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-07 P080011-S203 comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-06-16 P080011-S202 comflicon A Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-05-04 P080011-S201 Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-04-09 P080011-S200 Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-03-18 P080011-S199 Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-03-04 P080011-S198 Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-03-04 P080011-S197 Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-02-17 P180035-S034 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2026-02-10 P080011-S196 Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-02-02 P080011-S195 Biofmity XR Torie (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2026-01-07 P080011-S194 comfilcon A Soft (Hydrophilic) Contact Lenses for daily wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-12-23 P180035-S033 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-12-17 P180035-S032 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-12-11 P080011-S193 Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-12-05 P080011-S191 Sofmed® breathables™ XW NEXT Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-10-28 P180035-S031 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-09-22 P080011-S192 Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-08-20 P080011-S186 iWear oxygen presbyopia Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-08-20 P080011-S184 up&up Monthly Performance + Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-07-30 P180035-S030 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-07-23 P080011-S180 up&up Monthly Performance, up&up Monthly Performance XR, up&up Monthly Performance for Astigmatism, up&up Monthly Perfor Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-07-14 P080011-S190 Biofinity XR Toric (comfilcon A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-06-23 P080011-S189 comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-06-17 P180035-S029 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-06-17 P180035-S028 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-05-20 P080011-S188 Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-05-14 P180035-S027 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-05-05 P180035-S026 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-05-02 P080011-S187 Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-03-25 P080011-S185 Biofinity Sphere (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-03-17 P080011-S183 BIOFINITY (COMFILCON A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-03-12 P080011-S182 Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-02-25 P080011-S181 BIOFINITY (COMFILCON A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-02-20 P180035-S025 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2025-02-14 P080011-S179 Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-02-04 P080011-S178 Biofinity Sphere and Biofinity XR Sphere, Biofinity Torie and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energ 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2025-01-02 P080011-S177 Biofinity XR Toric and Biofinity Toric Multifocal comfilcon A Soft (Hydrophilic) Contact Lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-12-18 P080011-S176 BIOFINITY Toric (COMFILCON A) soft (hydrophilic) contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-12-18 P080011-S175 BIOFINITY (COMFILCON A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-11-15 P080011-S167 Ethos AquaTech Evolve Monthly Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-10-29 P080011-S174 BIOFINITY (COMFILCON A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-10-24 P080011-S172 Biofinity XR Toric, Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-10-22 P080011-S173 Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-10-07 P180035-S024 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2024-09-17 P080011-S171 Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric and Biofinity XR Torie and Biofinity Multifocal (comfilc 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-08-20 P180035-S023 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2024-08-20 P080011-S170 Comfilcon A Soft (Hydrophilic) contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-08-01 P180035-S022 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2024-07-30 P080011-S169 Biofinity Sphere (comfilcon A), Biofinity Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-07-23 P080011-S168 Biofinity (comflicon A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-07-16 P080011-S166 Biofinity Toric Multifocal and Biofinity XR Toric (comfilconA) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-07-10 P180035-S020 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2024-07-09 P080011-S164 Biofinity Sphere, Biofinity XR Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-07-03 P080011-S165 Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric, Biofinity XR Toric, Biofinity Multifo 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-06-12 P080011-S163 Biofinity Sphere (comfilcon A) 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-05-31 P180035-S021 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2024-05-24 P080011-S160 Biofinity XR Toric, Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-05-23 P080011-S162 Biofinity Sphere and Sphere XR, Biofinity Energys Asphere, Biofinity Toric, Biofinity Torie XR, Biofinity Multifoeal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-05-23 P080011-S161 Biofinity Toric Multifocal, Biofinity Toric XR 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2024-05-16 P080011-S159 Biofinity Sphere (comfilcon A), Biofinity Torie (comfilcon A), Biofinity XR Torie (comfilcon A), Biofinity Torie Multifo 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-12-20 P080011-S158 Biofinity Sphere, Biofinity Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-09-28 P080011-S157 Biofinity Sphere, Biofinity Torie, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (comfilcon A) Soft (Hydr 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-08-21 P080011-S156 Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-08-09 P080011-S155 Biofinity Sphere 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-06-09 P180035-S019 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-06-09 P180035-S018 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-04-24 P180035-S017 MiSight 1 day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-03-22 P180035-S016 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-02-15 P080011-S154 Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys, Biofinity Toric and Biofinity XR Toric, Biofinity Multifoca 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-01-19 P080011-S153 Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2023-01-13 P180035-S015 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-01-12 P180035-S013 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2023-01-10 P180035-S014 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2022-12-21 P080011-S152 Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-12-07 P180035-S012 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2022-12-07 P080011-S151 BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-11-21 P080011-S150 Biofinity, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-10-26 P080011-S149 Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-09-22 P180035-S011 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2022-09-19 P080011-S141 Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-09-15 P180035-S010 MiSight 1 day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2022-08-18 P080011-S148 Biofinity XR Toric, Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-08-15 P080011-S144 Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-08-15 P080011-S142 Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-08-08 P080011-S147 Biofinity Sphere, Biofinity Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-07-25 P080011-S146 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear Real-Time Process LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-06-16 P870024-S060 FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid Normal 180 Day Track No User Fee MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2022-06-09 P080011-S139 Biofinity Toric Multifocal Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-06-08 P870024-S059 Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin Real-Time Process MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2022-05-10 P870024-S062 Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an 30-Day Notice MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2022-05-10 P050031-S009 Paragon Z CRT, Paragon Z CRT Dual Axis 30-Day Notice NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic
2022-05-03 P080011-S145 Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-04-27 P080011-S143 Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-04-14 P080011-S140 Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-02-16 P080011-S138 Biofinity Energys 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-02-01 P080011-S131 Voyant Monthly, Voyant Monthly Premium, Voyant Monthly Toric, Voyant Monthly Multifocal Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-01-26 P180035-S009 MiSight 1 Day (omafilcon A) 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2022-01-06 P080011-S137 Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2022-01-04 P080011-S130 Pearle Vision Monthly Balance Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-12-10 P080011-S136 Biofinity Sphere, Biofinity Toric 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-11-19 P080011-S134 Biofinity XR Toric; Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-11-17 P080011-S133 Biofinity XR Toric, Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-11-08 P080011-S132 Biofinity XR Toric; Biofinity Toric Multifocal 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-07-26 P180035-S003 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2021-07-12 P180035-S004 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2021-06-04 P080011-S129 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-06-03 P080011-S120 Ethos AquaTech Monthly, Ethos AquaTech Monthly for Astigmatism, Ethos AquaTech Monthly Multifocal Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-05-20 P080011-S128 Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-05-06 P080011-S127 Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-04-23 P870024-S058 Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints Normal 180 Day Track No User Fee MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2021-04-22 P080011-S126 Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-04-15 P080011-S125 Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-04-06 P080011-S124 Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-03-26 P180035-S008 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2021-03-26 P180035-S007 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2021-03-02 P080011-S123 Biofinity (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-01-15 P080011-S122 Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-01-12 P080011-S121 Biofinity XR Toric (Comfilcon A) soft (Hydrophilic) contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-01-07 P080011-S112 Natural Eyes HydraWear™ XW Multifocal Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2021-01-05 P080011-S110 LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-11-17 P080011-S119 Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-11-05 P080011-S118 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-10-05 P080011-S117 Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-10-01 P080011-S106 Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 135 Review Track For 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-09-21 P080011-S116 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-09-16 P080011-S115 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-09-04 P080011-S114 Biofinity Energys (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-09-01 P850079-S089 Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-08-31 P870024-S057 Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin 30-Day Notice MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2020-08-31 P870024-S056 Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti 30-Day Notice MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2020-08-31 P050031-S007 Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints 30-Day Notice NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic
2020-08-31 P050031-S006 Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints 30-Day Notice NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic
2020-08-27 P080011-S113 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-08-18 P870024-S055 Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac 30-Day Notice MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2020-08-13 P870024-S054 Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints 30-Day Notice MWL Lens, Contact (Rigid Gas Permeable), Extended Wear Ophthalmic
2020-08-11 P080011-S111 Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-08-11 P080011-S109 Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-07-28 P850079-S088 Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-07-28 P080011-S108 Biofinity (comfilcon A) soft (hydrophilic) contact lenses for extended wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-07-28 P080011-S107 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-06-25 P180035-S006 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Real-Time Process QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2020-04-20 P870024-S053 Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin 30-Day Notice NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic
2020-04-20 P850079-S087 Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-04-20 P080011-S105 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-04-01 P080011-S104 Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-03-24 P080011-S103 Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-03-12 P850079-S086 Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-03-12 P180035-S005 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2020-03-12 P080011-S102 Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear 30-Day Notice LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-02-05 P180035-S001 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear Normal 180 Day Track No User Fee QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2020-02-04 P180035-S002 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses 30-Day Notice QIT Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia Unknown
2020-01-28 P080011-S098 Pearle Vision Monthly Multifocal Normal 180 Day Track No User Fee LPM Lenses, Soft Contact, Extended Wear Ophthalmic
2020-01-10 P050031-S004 Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint Real-Time Process NUU Lens, Contact, Orthokeratology, Overnight Ophthalmic
Safety

Recalls (26)

Class I (serious)
0
Risk of injury / death
Total recalls
26
Currently ongoing
12
Most recent
2025-08-22
DateSeverityStatusRecall # ProductCodeReason
2025-08-22 Class II Ongoing Z-2608-2025 Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,… — One lot manufactured with an invalid sterilization cycle.
2025-08-22 Class II Ongoing Z-2607-2025 Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo… — One lot manufactured with an invalid sterilization cycle.
2025-08-22 Class II Ongoing Z-2606-2025 MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si… — One lot manufactured with an invalid sterilization cycle.
2025-06-16 Class II Ongoing Z-2166-2025 Biofinity Toric Multifocal Contact Lens — Lens blisters may have an incomplete or leaking seal which may render them unsterile.
2025-06-16 Class II Ongoing Z-2165-2025 Biofinity XR Toric Contact Lens — Lens blisters may have an incomplete or leaking seal which may render them unsterile.
2025-02-27 Class II Ongoing Z-1455-2025 Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 … — a limited number of lots were manufactured with an incorrect cylinder power.
2024-08-29 Class II Ongoing Z-3311-2024 Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w… — Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
2024-08-29 Class II Ongoing Z-3310-2024 BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti… — Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
2023-02-14 Class II Ongoing Z-1282-2023 Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 — The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
2023-01-26 Class II Ongoing Z-1198-2023 Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) — Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
2023-01-26 Class II Ongoing Z-1197-2023 Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) — Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
2022-12-27 Class II Ongoing Z-1014-2023 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use. — Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
2021-05-19 Class II Terminated Z-2154-2021 SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2153-2021 FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2152-2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2151-2021 MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2150-2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2149-2021 CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2148-2021 SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2147-2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2146-2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2145-2021 FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2144-2021 AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2021-05-19 Class II Terminated Z-2143-2021 CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker — Misaligned placement of an axis mark can cause the patient to experience blurred vision
2020-01-13 Class II Terminated Z-1228-2020 Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear) — Incorrect power of lenses than the expected
2020-01-13 Class II Terminated Z-1227-2020 Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear) — Incorrect power of lenses than the expected
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2024-01-25 K234127 Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker LPL Class II Ophthalmic
2022-02-04 K220070 MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens LPL Class II Ophthalmic
2021-10-26 K213164 Avaira Vitality LPL Class II Ophthalmic
2020-10-20 K202756 Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) LPL Class II Ophthalmic
2020-03-23 K191763 MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC LPL Class II Ophthalmic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence