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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Aquair (enfilcon A) Soft (hydrophilic) Contact Lens	K071736	FDA 510(k)	Class II	Active
Dental Ultrasonic Scaler/Endosonic	K840141	FDA 510(k)	Class II	Active
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker	K234127	FDA 510(k)	Class II	Active
Resubmitted Diode Laser Coagulator	K882372	FDA 510(k)	Class II	Active
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)	K202756	FDA 510(k)	Class II	Active
In-Line Ophthalmic Irrigating Solution Filters	K871854	FDA 510(k)	Class II	Active
Mendez U/S Cystotome	K843386	FDA 510(k)	Class II	Active
Sus (stenfilcon A) Contact Lens	K131378	FDA 510(k)	Class II	Active
Smartknife System	K853063	FDA 510(k)	Class I	Active
Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200t Multifocal Toric	K050717	FDA 510(k)	Class II	Active
Automatic Tangent Screen 50	K832800	FDA 510(k)	Class I	Active
Ultrasonic Tips	K812126	FDA 510(k)	Class II	Active
Proclear Toric Xr Soft (hydrophilic) Contact Lens; Proclear Multifocal Xr Soft (hydrophilic) Contact Lens; Proclear Mult	K110099	FDA 510(k)	Class II	Active
Proclear Multifocal Toric And Xr And Toric Xr	K081865	FDA 510(k)	Class II	Active
Permalid Liner Pak	K842814	FDA 510(k)	N/A	Active
Avaira Avaira Toric Avaira Multifocal	K113245	FDA 510(k)	Class II	Active
Poly-Sleeve	K853631	FDA 510(k)	N/A	Active
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker	K181920	FDA 510(k)	Class II	Active
Epsilon Ultrasonic Tip	K831836	FDA 510(k)	Class II	Active
MyDay	K190965	FDA 510(k)	Class II	Active
Cilco Sonometrics Digicon	K854653	FDA 510(k)	Class II	Active
Series Ten Thousand Ocutome	K871871	FDA 510(k)	Class II	Active
Preference Standard, Preference Toric, Cooper Toric, Cooperclear, Cooperht, Cb 43, Vantage, Vantage Accents	K980649	FDA 510(k)	Class II	Active
Kratz Nova-Sert. Soft Intraocular Lens Injector	K870265	FDA 510(k)	Class I	Active
Dispos. I/A & Irrigation Handpieces	K833783	FDA 510(k)	Class II	Active
Series Ten Thousand Compact	K861565	FDA 510(k)	Class II	Active
Pachymeter System V	K864336	FDA 510(k)	Class II	Active
Aquasoft (tetrafilcon A) Daily Wear Soft (hydrophilic) Contact Lens	K954139	FDA 510(k)	Class II	Active
Electric Instrument Table	K832073	FDA 510(k)	Class I	Active
Cooper Vision I/A System Iii Model 1500	K822220	FDA 510(k)	Class II	Active
Micro-Mitt	K830821	FDA 510(k)	Class I	Active
Coopervision Acap Power Drive Ultrasonic Anterior	K854375	FDA 510(k)	Class II	Active
Kcp Pak #2 Convenience Pack Modification	K850275	FDA 510(k)	Class II	Active
Cavitron/Kelman Phaco-Emulsifier Aspira	K842979	FDA 510(k)	Class II	Active
Proclear Compatibles Multifocal	K032873	FDA 510(k)	Class II	Active
Series Ten Thousand Master	K861380	FDA 510(k)	Class II	Active
Biopmedics52, 52 1day, 52 Toric, 52 1day Toric	K113267	FDA 510(k)	Class II	Active
Optical Markers/Fixation Ring/Cannu & Irriga Cannu	K861535	FDA 510(k)	Class I	Active
Hydrasoft (east) And Hydrasoft Toric(east) (methafilcon B) Daily Wear Soft Hydrophilic Contact Lens	K962185	FDA 510(k)	Class II	Active
Preference 60 And Preference 60 Toric	K963013	FDA 510(k)	Class II	Active
Cooper Prosthetic	K042435	FDA 510(k)	Class II	Active
Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens	K061948	FDA 510(k)	Class II	Active
Avaira (enfilcon A) Contact Lens	K113759	FDA 510(k)	Class II	Active
R Pak	K851203	FDA 510(k)	U	Active
Disposable I/A Handpiece	K833784	FDA 510(k)	Class II	Active
Lensine Extra Strength Cleaner	K812433	FDA 510(k)	U	Active
Lensometer	K832085	FDA 510(k)	N/A	Active
Micro Cise Diamond Scalpel	K820730	FDA 510(k)	Class I	Active
Cavitron/Kelman Phacoemulsifier Aspirator, Univ.	K890635	FDA 510(k)	Class II	Active
Horizon(tm) Yag Laser Model 2000	P850001	FDA PMA	Class III	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