CooperVision, Inc.
Scottsville, NY, US
COOPERVISION INC. appears in FDA device records in Scottsville, NY. FDA records list 97 510(k) clearances between and , 573 PMA records and 4 registered establishments. As of , FDA records show 38 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 97FDA records hold 97 510(k) clearances for CooperVision, Inc. between 1978 and 2024. The busiest year on record is 1985, with 13. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 2 |
| 1982 | 2 |
| 1983 | 11 |
| 1984 | 11 |
| 1985 | 13 |
| 1986 | 7 |
| 1987 | 6 |
| 1988 | 3 |
| 1989 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 4 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 5 |
| 2012 | 1 |
| 2013 | 3 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | |
| K213164 | Avaira Vitality | LPL | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | LPL | Substantially Equivalent | |
| K190965 | MyDay | LPL | Substantially Equivalent | |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | |
| K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | |
| K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | LPL | Substantially Equivalent | |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | LPL | Substantially Equivalent | |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | LPL | Substantially Equivalent | |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | LPL | Substantially Equivalent | |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT | LPL | Substantially Equivalent | |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | LPL | Substantially Equivalent | |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | |
| K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | |
| K050717 | PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC | LPL | Substantially Equivalent | |
| K042824 | FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K042435 | COOPER PROSTHETIC | LPL | Substantially Equivalent | |
| K041138 | LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS | LPL | Substantially Equivalent | |
| K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | LPL | Substantially Equivalent | |
| K020392 | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR | LPL | Substantially Equivalent | |
| K002625 | METHAFILCON A | LPL | Substantially Equivalent | |
| K001090 | METHAFILCON A | LPL | Substantially Equivalent | |
| K001089 | POLYMACON | LPL | Substantially Equivalent | |
| K000384 | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX | LPL | Substantially Equivalent | |
| K993252 | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP | MVN | Substantially Equivalent | |
| K990606 | TETRAFILCON A | LPL | Substantially Equivalent | |
| K980649 | PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS | LPL | Substantially Equivalent | |
| K963013 | PREFERENCE 60 AND PREFERENCE 60 TORIC | LPL | Substantially Equivalent | |
| K962185 | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS | LPL | Substantially Equivalent | |
| K954139 | AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | |
| K950968 | TETRAFILCON A HYDROPHILIC CONTACT LENSES | LPL | Substantially Equivalent | |
| K890635 | CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. | HQC | Substantially Equivalent | |
| K890300 | INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE | HQE | Substantially Equivalent | |
| K882372 | RESUBMITTED DIODE LASER COAGULATOR | HQF | Substantially Equivalent | |
| K881095 | KOI(TM) INSTRUMENT TRAYS | LRP | Substantially Equivalent | |
| K881094 | KOI(TM) BLADE GAUGE, MODEL KOI-132 | HOE | Substantially Equivalent | |
| K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS | GEA | Substantially Equivalent | |
| K871854 | IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS | HQC | Substantially Equivalent | |
| K871871 | SERIES TEN THOUSAND OCUTOME | HQE | Substantially Equivalent | |
| K871440 | KRATZ NOVA-SERT | KYB | Substantially Equivalent | |
| K870265 | KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR | KYB | Substantially Equivalent | |
| K864336 | PACHYMETER SYSTEM V | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005724763 | 3005724763 | COOPERVISION INC. | 180 THRUWAY PARK DR., W Henrietta, NY 14586 US | 2026 | |
| 1314956 | 1314956 | COOPERVISION, INC. | 711 NORTH RD., SCOTTSVILLE, NY 14546 US | 2026 | |
| 9614374 | 3002807783 | CooperVision Limited | 36 SCHOOL LANE, Eastleigh Hampshire SO53 4LY GB | 2026 | |
| 3011771819 | 3011771819 | CooperVision, Inc. | 209 High Point, Victor, NY 14564 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- HOECaliper, Ophthalmic
- GEACannula, Surgical, General & Plastic Surgery
- HOXChart, Visual Acuity
- FXPCover, Shoe, Operating-Room
- HNYCystotome
- QITDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia
- HMTDrape, Patient, Ophthalmic
- HNRForceps, Ophthalmic
- LFLInstrument, Ultrasonic Surgical
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered
- HNNKnife, Ophthalmic
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- HQFLaser, Ophthalmic
- MUWLens, Contact (Orthokeratology)
- HQDLens, Contact (Other Material) - Daily
- HPXLens, Contact (Polymethylmethacrylate)
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear
- MVNLens, Contact, (Disposable)
- NUULens, Contact, Orthokeratology, Overnight
- KYBLens, Guide, Intraocular
- LPLLenses, Soft Contact, Daily Wear
- LPMLenses, Soft Contact, Extended Wear
- HMRMarker, Ocular
- HOOPerimeter, Ac-Powered
- HPTPerimeter, Automatic, Ac-Powered
- GEXPowered Laser Surgical Instrument
- HNLProbe, Lachrymal
- ELCScaler, Ultrasonic
- GDXScalpel, One-Piece
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HKXTonometer, Ac-Powered
- LRPTray, Surgical
- HQCUnit, Phacofragmentation
Recall records
Showing 25 of 38| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2608-2025 | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. | One lot manufactured with an invalid sterilization cycle. | Class II | Open, Classified | |
| Z-2607-2025 | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. | One lot manufactured with an invalid sterilization cycle. | Class II | Open, Classified | |
| Z-2606-2025 | MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. | One lot manufactured with an invalid sterilization cycle. | Class II | Open, Classified | |
| Z-2166-2025 | Biofinity Toric Multifocal Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | Open, Classified | |
| Z-2165-2025 | Biofinity XR Toric Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | Open, Classified | |
| Z-1455-2025 | 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 | a limited number of lots were manufactured with an incorrect cylinder power. | Class II | Open, Classified | |
| Z-3311-2024 | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity | Class II | Open, Classified | |
| Z-3310-2024 | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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 | Class II | Open, Classified | |
| 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 | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain