CooperVision, Inc.
Medical device manufacturer in West Henrietta, NY.
97510(k) clearances
8PMA approvals
37recalls
Device types
- LPL Lenses, Soft Contact, Daily Wear 37
- HQC Unit, Phacofragmentation 15
- HQE Instrument, Vitreous Aspiration And… 7
- HQF Laser, Ophthalmic 3
- IYO System, Imaging, Pulsed Echo, Ultrasonic 3
- HKX Tonometer, Ac-Powered 2
- MVN Lens, Contact, (Disposable) 2
- HPX Lens, Contact (Polymethylmethacrylate) 2
- KYB Lens, Guide, Intraocular 2
- HOX Chart, Visual Acuity 1
- HMT Drape, Patient, Ophthalmic 1
- FXP Cover, Shoe, Operating-Room 1
- HNY Cystotome 1
- HKP Instrument, Vitreous Aspiration And… 1
- HPT Perimeter, Automatic, Ac-Powered 1
- HMF Stand, Instrument, Ac-Powered, Ophthalmic 1
- HOO Perimeter, Ac-Powered 1
- HNL Probe, Lachrymal 1
- GDX Scalpel, One-Piece 1
- GEX Powered Laser Surgical Instrument 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…LPL · Special | 10/20/2020SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
| K123202 | Proclear (Omafilcon a) Soft Hydrophilic) Contact LensLPL · Special | 05/30/2013SE |
| K113759 | Avaira (Enfilcon a) Contact LensLPL · Special | 04/03/2012SE |
| K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…LPL · Traditional | 12/21/2011SE |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY ToricLPL · Special | 12/02/2011SE |
| K113245 | Avaira Avaira Toric Avaira MultifocalLPL · Special | 12/02/2011SE |
| K111966 | Proclear, Proclear Toric, Proclear Multifocal, Proclear 1DAY, Proclear XCLPL · Special | 09/15/2011SE |
| K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft…LPL · Traditional | 06/29/2011SE |
| K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensLPL · Traditional | 01/05/2010SE |
| K081865 | Proclear Multifocal Toric and XR and Toric XRLPL · Special | 09/29/2008SE |
| K071736 | Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensLPL · Traditional | 01/04/2008SE |
| K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensMVN · Traditional | 11/22/2006SE |
| K052560 | Biofinity (Comfilcon a) Soft Contact LensLPL · Traditional | 12/06/2005SE |
| K050717 | Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal…LPL · Traditional | 05/13/2005SE |
| K042824 | Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensLPL · Traditional | 11/16/2004SE |
| K042435 | Cooper ProstheticLPL · Traditional | 10/26/2004SE |
| K041138 | Leo Colors, Leo Aspheric Colors, Leo Toric ColorsLPL · Traditional | 07/23/2004SE |
| K032873 | Proclear Compatibles MultifocalLPL · Traditional | 11/07/2003SE |
| K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily WearLPL · Traditional | 04/26/2002SE |
| K002625 | Methafilcon aLPL · Traditional | 09/13/2000SE |
| K001090 | Methafilcon aLPL · Traditional | 05/19/2000SE |
| K001089 | PolymaconLPL · Traditional | 05/19/2000SE |
| K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, CooperflexLPL · Special | 03/06/2000SE |
| K993252 | Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be…MVN · Traditional | 11/24/1999SE |
| K990606 | Tetrafilcon aLPL · Special | 03/15/1999SE |
| K980649 | Preference Standard, Preference Toric, Cooper Toric, Cooperclear, Cooperht, CB 43…LPL · Traditional | 05/13/1998SE |
| K963013 | Preference 60 and Preference 60 ToricLPL · Traditional | 12/19/1997SE |
| K962185 | Hydrasoft (East) and Hydrasoft Toric(East) (Methafilcon B) Daily Wear Soft Hydrophilic…LPL · Traditional | 12/17/1996SE |
| K954139 | Aquasoft (Tetrafilcon a) Daily Wear Soft (Hydrophilic) Contact LensLPL · Traditional | 11/24/1995SE |
| K950968 | Tetrafilcon a Hydrophilic Contact LensesLPL · Traditional | 07/25/1995SE |
| K890635 | Cavitron/Kelman Phacoemulsifier Aspirator, Univ.HQC · Traditional | 05/09/1989SE |
| K890300 | Intercassette, Interkit, Universal Pak & CassetteHQE · Traditional | 04/17/1989SE |
| K882372 | Resubmitted Diode Laser CoagulatorHQF · Traditional | 08/02/1988SE |
| K881095 | Koi(Tm) Instrument TraysLRP · Traditional | 04/06/1988SE |
| K881094 | Koi(Tm) Blade Gauge, Model KOI-132HOE · Traditional | 04/01/1988SE |
| K872214 | Cooper Surg Aspiration Cannula/Custom Conven PaksGEA · Traditional | 08/17/1987SE |
| K871854 | In-Line Ophthalmic Irrigating Solution FiltersHQC · Traditional | 07/27/1987SE |
| K871871 | Series Ten Thousand OcutomeHQE · Traditional | 06/11/1987SE |
| K871440 | Kratz Nova-SertKYB · Traditional | 05/07/1987SE |
| K870265 | Kratz Nova-Sert. Soft Intraocular Lens InjectorKYB · Traditional | 02/20/1987SE |
| K864336 | Pachymeter System VIYO · Traditional | 01/09/1987SE |
| K862987 | Model 1000 Ophthalmic Laser SystemHQF · Traditional | 09/24/1986SE |
| K854653 | Cilco Sonometrics DigiconIYO · Traditional | 09/04/1986SE |
| K861565 | Series Ten Thousand CompactHQE · Traditional | 07/11/1986SE |
| K861380 | Series Ten Thousand MasterHQE · Traditional | 07/11/1986SE |
| K861535 | Optical Markers/Fixation Ring/Cannu & Irriga CannuHMR · Traditional | 05/14/1986SE |
| K861141 | Manual Ophthalmic Surgical InstrumentsHNR · Traditional | 04/24/1986SE |
| K854949 | Model 9500 Argon, Krypton & Dye Surgical Laser SysHQF · Traditional | 02/04/1986SE |
| K854375 | Coopervision Acap Power Drive Ultrasonic AnteriorHQC · Traditional | 12/27/1985SE |
| K853063 | Smartknife SystemHNN · Traditional | 11/04/1985SN |
| K853631 | Poly-Sleeve · Traditional | 11/01/1985SE |
| K853070 | Cooper Vision System Vi U/S ModuleHQC · Traditional | 08/20/1985SE |
| K852271 | Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001HQE · Traditional | 08/09/1985SE |
| K842814 | Permalid Liner Pak · Traditional | 08/01/1985SN |
| K842781 | Permalid Pak · Traditional | 08/01/1985SESD |
| K851203 | R PakLFL · Traditional | 07/23/1985SE |
| K843915 | Mini-Halo CO2 Laser SystemGEX · Traditional | 05/10/1985SE |
| K850275 | KCP Pak #2 Convenience Pack ModificationHQC · Traditional | 04/15/1985SE |
| K850149 | KCP (Kelman Compact Phaco-Emulsifier) PeaHQC · Traditional | 04/15/1985SE |
| K850148 | KCP Pak Convenience PackHQC · Traditional | 04/15/1985SE |
| K842757 | Ultrascan Digital BIYO · Traditional | 01/09/1985SE |
| K842945 | Coopervision System ViHQC · Traditional | 12/11/1984SE |
| K843386 | Mendez U/S CystotomeHQC · Traditional | 11/27/1984SE |
| K842979 | Cavitron/Kelman Phaco-Emulsifier AspiraHQC · Traditional | 11/27/1984SE |
| K840836 | Cat 100HKX · Traditional | 06/19/1984SE |
| K840141 | Dental Ultrasonic Scaler/EndosonicELC · Traditional | 03/16/1984SE |
| K833465 | Disposable Fiber Optic IlluminatorHQC · Traditional | 03/15/1984SE |
| K833783 | Dispos. I/A & Irrigation HandpiecesHQC · Traditional | 03/05/1984SE |
| K833784 | Disposable I/A HandpieceHQC · Traditional | 02/21/1984SE |
| K833671 | Sterile Oil and GuidewireHNL · Traditional | 01/10/1984SE |
| K833494 | Clerz Lubricating/Rewetting SolutionHKX · Traditional | 01/04/1984SE |
| K833371 | Disposable Ocutome ProbeHQE · Traditional | 01/04/1984SE |
| K832800 | Automatic Tangent Screen 50HOO · Traditional | 09/29/1983SE |
| K832085 | Lensometer · Traditional | 08/16/1983SE |
| K832073 | Electric Instrument TableHMF · Traditional | 08/12/1983SE |
| K832142 | Dicon Glaucoma Diag. Center 2000 SeriesHPT · Traditional | 08/01/1983SE |
| K832074 | Cavitron/Kelman Phaco-Emulsifier AspiraHKP · Traditional | 08/01/1983SE |
| K831916 | Disposable CystotomeHNY · Traditional | 07/12/1983SE |
| K831836 | Epsilon Ultrasonic TipHQC · Traditional | 06/30/1983SE |
| K830740 | Clerz Lubricating & Rewetting Eye DropsHPX · Traditional | 06/02/1983SE |
| K830821 | Micro-MittFXP · Traditional | 04/27/1983SE |
| K830822 | Eye DrapeHMT · Traditional | 04/06/1983SE |
| K830011 | VFS 1000/SCREENING Function AnalyzerHOX · Traditional | 01/17/1983SE |
| K822220 | Cooper Vision I/A System III Model 1500HQE · Traditional | 10/06/1982SE |
| K820730 | Micro Cise Diamond ScalpelGDX · Traditional | 04/09/1982SE |
| K812433 | Lensine Extra Strength CleanerHPX · Traditional | 09/21/1981SE |
| K812126 | Ultrasonic TipsHQC · Traditional | 09/18/1981SE |
| K780872 | Cytology BrushBTG · Traditional | 09/07/1978SE |
PMA approvals
- P180035 MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear · 11/15/2019 · 34 supplements
- P080011 Biofinity (Comfilcon a) · 11/19/2008 · 201 supplements
- P050031 Paragon Z CRT (Tisilfocon a) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy · 11/16/2006 · 7 supplements
- P870024 Fluoroperm RGP Contact Lenses · 12/31/1987 · 56 supplements
- P850079 Hydrasoft (Methafilcon B) Contact Lens · 01/31/1986 · 82 supplements
- P850077 Sunsoft (Methafilocn a) Hydrophilic Contact Lens · 01/31/1986 · 20 supplements
- P780010 Permalens (Perfilcon a) Soft Hydrophilic Contact Lens · 06/11/1979 · 15 supplements
- P780007 Hydron Hydrophilic Contact Lens · 04/06/1979 · 54 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3248-2026 | Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog…A small number of lenses within the affected lot are of the incorrect power. | 08/12/2026Open, Classified |
| Z-2608-2025 Class II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day…One lot manufactured with an invalid sterilization cycle. | 08/22/2025Open, Classified |
| Z-2607-2025 Class II | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54%…One lot manufactured with an invalid sterilization cycle. | 08/22/2025Open, Classified |
| Z-2606-2025 Class II | MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water…One lot manufactured with an invalid sterilization cycle. | 08/22/2025Open, Classified |
| Z-2166-2025 Class II | Biofinity Toric Multifocal Contact LensLens blisters may have an incomplete or leaking seal which may render them unsterile. | 06/16/2025Open, Classified |
| Z-2165-2025 Class II | Biofinity XR Toric Contact LensLens blisters may have an incomplete or leaking seal which may render them unsterile. | 06/16/2025Open, Classified |
| Z-1455-2025 Class II | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses…a limited number of lots were manufactured with an incorrect cylinder power. | 02/27/2025Open, Classified |
| Z-3311-2024 Class II | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of…Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual… | 08/29/2024Open, Classified |
| Z-3310-2024 Class II | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of…Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual… | 08/29/2024Open, Classified |
| Z-1282-2023 Class II | Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the… | 02/14/2023Open, Classified |
| Z-1198-2023 Class II | 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… | 01/26/2023Open, Classified |
| Z-1197-2023 Class II | 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… | 01/26/2023Open, Classified |
| Z-1014-2023 Class II | MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens…Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity. | 12/27/2022Open, Classified |
| Z-2154-2021 Class II | SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2153-2021 Class II | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2152-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2151-2021 Class II | MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2150-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2149-2021 Class II | CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2148-2021 Class II | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2147-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2146-2021 Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2145-2021 Class II | FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2144-2021 Class II | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV…Misaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-2143-2021 Class II | CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerMisaligned placement of an axis mark can cause the patient to experience blurred vision | 05/19/2021Terminated |
| Z-1228-2020 Class II | Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic)…Incorrect power of lenses than the expected | 01/13/2020Terminated |
| Z-1227-2020 Class II | Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic)…Incorrect power of lenses than the expected | 01/13/2020Terminated |
| Z-1518-2018 Class III | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-1517-2018 Class III | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-1516-2018 Class III | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-1515-2018 Class III | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily…The secondary packaging is labeled with an incorrect expiration date. | 02/21/2018Terminated |
| Z-0691-2018 Class III | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft…The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The… | 09/01/2017Terminated |
| Z-0543-2014 Class II | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for…Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package… | 11/20/2013Terminated |
| Z-0542-2014 Class II | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE…Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package… | 11/20/2013Terminated |
| Z-0350-2012 | AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses…Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses. | 11/15/2011Terminated |
| Z-0044-2012 | AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES…This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from… | 08/19/2011Terminated |
| Z-0125-2010 | ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for…Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under… | 08/28/2009Terminated |