Data / Medical devices / United States / Coopervision Inc.
Coopervision Inc.: FDA-registered device maker in W Henrietta, NY, United States, 18 510(k) clearances and 4 PMA approvals
Coopervision Inc. is registered with the FDA (registration 3005724763) in W Henrietta, NY, United States. It lists 4 device types. The FDA files 18 510(k) clearances and 4 PMA approvals under its listings, the newest dated January 25, 2024. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005724763
- Address
- 180 Thruway Park DR., W Henrietta, NY, United States, 14586
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Repackager or relabeler
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- Avaira Vitality Sphere, Avaira Vitality Toric, BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | 3 | Repackager or relabeler | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2024 | K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| February 4, 2022 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 26, 2021 | K213164 | Avaira Vitality | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| October 20, 2020 | 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 | CooperVision, Inc. | accessdata.fda.gov |
| April 29, 2019 | K190965 | MyDay | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 5, 2013 | K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | LPL | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| July 26, 2013 | K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER | MVN | Substantially Equivalent | Sauflon Pharmaceuticals, Ltd. | accessdata.fda.gov |
| December 21, 2011 | K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| January 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| December 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 7, 2003 | K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| January 21, 1999 | K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| August 20, 1997 | K972303 | OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS | LPL | Substantially Equivalent | Ocular Sciences Puerto Rico, Inc. | accessdata.fda.gov |
| April 3, 1997 | K970095 | PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Biocompatibles Eyewear, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 15, 2019 | P180035 | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | QIT | 34 | February 17, 2026 | accessdata.fda.gov |
| November 19, 2008 | P080011 | BIOFINITY (COMFILCON A) | LPM | 201 | September 2, 2026 | accessdata.fda.gov |
| September 19, 1989 | P890023 | H55 HYDROPHILIC CONTACT LENS | LPM | 53 | December 11, 2025 | accessdata.fda.gov |
| January 31, 1986 | P850079 | HYDRASOFT (METHAFILCON B) CONTACT LENS | LPM | 82 | September 1, 2020 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 22, 2026 | 99936 | Class II | Ongoing | Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel co | The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for exte | accessdata.fda.gov |
| August 12, 2026 | 99766 | Class II | Ongoing | Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day | A small number of lenses within the affected lot are of the incorrect power. | accessdata.fda.gov |
| August 22, 2025 | 97515 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 27, 2025 | 96396 | Class II | Ongoing | 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 To | a limited number of lots were manufactured with an incorrect cylinder power. | accessdata.fda.gov |
| August 29, 2024 | 95299 | Class II | Ongoing | 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 | accessdata.fda.gov |
| February 14, 2023 | 91793 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 26, 2023 | 91607 | Class II | Ongoing | 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 | accessdata.fda.gov |
| December 27, 2022 | 91389 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 19, 2021 | 88096 | Class II | Terminated | 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 | accessdata.fda.gov |
| January 13, 2020 | 84725 | Class II | Terminated | 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 | accessdata.fda.gov |
| February 21, 2018 | 79755 | Class III | Terminated | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated fo | The secondary packaging is labeled with an incorrect expiration date. | accessdata.fda.gov |
| September 1, 2017 | 79073 | Class III | Terminated | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non | 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. | accessdata.fda.gov |
| November 20, 2013 | 66844 | Class II | Terminated | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. | accessdata.fda.gov |
| August 19, 2011 | 60008 | Not yet classified | Terminated | AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. | 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 | accessdata.fda.gov |
| August 28, 2009 | 53532 | Not yet classified | Terminated | ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied steril | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Lenses, Soft Contact, Extended Wear
Updated October 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.