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COOPERVISION INC.

Last updated September 17, 2026

Information

Country: US
Address: 180 THRUWAY PARK DR., W Henrietta, NY, 14586
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005724763
DUNS Number: —

Catalogue (111)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
CooperVision Refine One Step	NA	FDA UDI	Class II	Active
CooperVision Refine One Step	NA	FDA UDI	Class II	Active
CooperVision Lite Multipurpose Solution	NA	FDA UDI	Class II	Active
Aquaclear	NA	FDA UDI	Class II	Active
Ascend	NA	FDA UDI	Class II	Active
CooperVision Lite Multipurpose Solution	NA	FDA UDI	Class II	Active
Aquaclear	NA	FDA UDI	Class II	Active
Aquaclear	NA	FDA UDI	Class II	Active
Aquaclear	NA	FDA UDI	Class II	Active
Model 1000 Ophthalmic Laser System	K862987	FDA 510(k)	Class II	Active
Disposable Ocutome Probe	K833371	FDA 510(k)	Class II	Active
Coopervision System Vi	K842945	FDA 510(k)	Class II	Active
Kratz Nova-Sert	K871440	FDA 510(k)	Class I	Active
Koi(tm) Instrument Trays	K881095	FDA 510(k)	Class I	Active
Eye Drape	K830822	FDA 510(k)	Class II	Active
Clerz Lubricating/Rewetting Solution	K833494	FDA 510(k)	Class II	Active
Manual Ophthalmic Surgical Instruments	K861141	FDA 510(k)	Class I	Active
Cooper Vision System Vi U/S Module	K853070	FDA 510(k)	Class II	Active
Sterile Oil And Guidewire	K833671	FDA 510(k)	Class I	Active
Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001	K852271	FDA 510(k)	Class II	Active
Cat 100	K840836	FDA 510(k)	Class II	Active
Proclear (omafilcon A) Soft Hydrophilic) Contact Lens	K123202	FDA 510(k)	Class II	Active
Kcp (kelman Compact Phaco-Emulsifier) Pea	K850149	FDA 510(k)	Class II	Active
Permalid Pak	K842781	FDA 510(k)	N/A	Active
Dicon Glaucoma Diag. Center 2000 Series	K832142	FDA 510(k)	Class I	Active
Cooper Surg Aspiration Cannula/Custom Conven Paks	K872214	FDA 510(k)	Class I	Active
Leo Colors, Leo Aspheric Colors, Leo Toric Colors	K041138	FDA 510(k)	Class II	Active
Avaira Vitality	K213164	FDA 510(k)	Class II	Active
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC	K191763	FDA 510(k)	Class II	Active
Frequency 55 Uv (methafilcon A) Soft (hydrophlic) Contact Lens For Daily Wear	K020392	FDA 510(k)	Class II	Active
Cytology Brush	K780872	FDA 510(k)	Class II	Active
Koi(tm) Blade Gauge, Model Koi-132	K881094	FDA 510(k)	Class I	Active
Methafilcon A Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 Uv (to Be Marketed Yr. 2000), Frequency 55 Asp	K993252	FDA 510(k)	Class II	Active
Proclear Toric Xr, Proclear Multifocal Xr, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses	K112302	FDA 510(k)	Class II	Active
Frequency 38 And Silver 07 (polymacon) Soft (hydrophilic) Contact Lens	K042824	FDA 510(k)	Class II	Active
Cavitron/Kelman Phaco-Emulsifier Aspira	K832074	FDA 510(k)	Class II	Active
Mini-Halo Co2 Laser System	K843915	FDA 510(k)	Class II	Active
Kcp Pak Convenience Pack	K850148	FDA 510(k)	Class II	Active
Vfs 1000/Screening Function Analyzer	K830011	FDA 510(k)	Class I	Active
Ultrascan Digital B	K842757	FDA 510(k)	Class II	Active
Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex	K000384	FDA 510(k)	Class II	Active
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	K220070	FDA 510(k)	Class II	Active
Intercassette, Interkit, Universal Pak & Cassette	K890300	FDA 510(k)	Class II	Active
Disposable Fiber Optic Illuminator	K833465	FDA 510(k)	Class II	Active
Model 9500 Argon, Krypton & Dye Surgical Laser Sys	K854949	FDA 510(k)	Class II	Active
Disposable Cystotome	K831916	FDA 510(k)	Class I	Active
Biofinity (comfilcon A) Soft Contact Lens	K052560	FDA 510(k)	Class II	Active
Proclear, Proclear Toric, Proclear Multifocal, Proclear 1day, Proclear Xc	K111966	FDA 510(k)	Class II	Active
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens	K160803	FDA 510(k)	Class II	Active
Avaira Spheric And Toric (enfilcon A) Soft Contact Lens	K133627	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (38)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 22, 2025	Z-2606-2025	—	open, classified	One lot manufactured with an invalid sterilization cycle.
Aug 22, 2025	Z-2608-2025	—	open, classified	One lot manufactured with an invalid sterilization cycle.
Aug 22, 2025	Z-2607-2025	—	open, classified	One lot manufactured with an invalid sterilization cycle.
Jun 16, 2025	Z-2166-2025	—	open, classified	Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Jun 16, 2025	Z-2165-2025	—	open, classified	Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Feb 27, 2025	Z-1455-2025	—	open, classified	a limited number of lots were manufactured with an incorrect cylinder power.
Aug 29, 2024	Z-3311-2024	—	open, classified	Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Aug 29, 2024	Z-3310-2024	—	open, classified	Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Feb 14, 2023	Z-1282-2023	—	open, classified	The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Jan 26, 2023	Z-1197-2023	—	open, classified	Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Jan 26, 2023	Z-1198-2023	—	open, classified	Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Dec 27, 2022	Z-1014-2023	—	open, classified	Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
May 19, 2021	Z-2150-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2154-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2153-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2147-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2151-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2143-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2152-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2146-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2144-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2148-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2145-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
May 19, 2021	Z-2149-2021	—	terminated	Misaligned placement of an axis mark can cause the patient to experience blurred vision
Jan 13, 2020	Z-1227-2020	—	terminated	Incorrect power of lenses than the expected
Jan 13, 2020	Z-1228-2020	—	terminated	Incorrect power of lenses than the expected
Feb 21, 2018	Z-1515-2018	—	terminated	The secondary packaging is labeled with an incorrect expiration date.
Feb 21, 2018	Z-1516-2018	—	terminated	The secondary packaging is labeled with an incorrect expiration date.
Feb 21, 2018	Z-1517-2018	—	terminated	The secondary packaging is labeled with an incorrect expiration date.
Feb 21, 2018	Z-1518-2018	—	terminated	The secondary packaging is labeled with an incorrect expiration date.
Sep 1, 2017	Z-0691-2018	—	terminated	The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.
Nov 20, 2013	Z-0543-2014	—	terminated	Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Nov 20, 2013	Z-0542-2014	—	terminated	Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Nov 15, 2011	Z-0350-2012	—	terminated	Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses.
Aug 19, 2011	Z-0044-2012	—	terminated	This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Corneal epithelial edema results when there is insufficient oxygen to the eye, which may be caused by the presence of residue on the lens. Through laboratory testing and investigation, the company determined the cause of the corneal epithelial edema was a small amount of residue (silicone oil) on the lens.
Aug 28, 2009	Z-0125-2010	—	terminated	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.
Jul 22, 2003	Z-1091-03	—	terminated	Mislabeled with incorrect sphere power.
Jun 25, 2003	Z-0978-03	—	terminated	The actual sphere power of the lens is lower than the labeled value.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

CooperVision Limited Eastleigh Hampshire · GB FEI 3002807783