CooperVision Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 33
- 510(k) Clearances
- 97
- Inspections
- 9
- Compliance Actions
- 1
Known Names
coopervision, coopervision-cilco, coopervision surgical, coopervision manufacturing costa rica, coopervision italia
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2607-2025 | Class II | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water con | August 22, 2025 |
| Z-2606-2025 | Class II | MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, To | August 22, 2025 |
| Z-2608-2025 | Class II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. | August 22, 2025 |
| Z-2166-2025 | Class II | Biofinity Toric Multifocal Contact Lens | June 16, 2025 |
| Z-2165-2025 | Class II | Biofinity XR Toric Contact Lens | June 16, 2025 |
| Z-1455-2025 | Class II | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmati | February 27, 2025 |
| Z-3311-2024 | Class II | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (m | August 29, 2024 |
| Z-3310-2024 | Class II | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or | August 29, 2024 |
| Z-1282-2023 | Class II | Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 | February 14, 2023 |
| Z-1198-2023 | Class II | Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) | January 26, 2023 |
| Z-1197-2023 | Class II | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) | January 26, 2023 |
| Z-1014-2023 | Class II | MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). | December 27, 2022 |
| Z-2151-2021 | Class II | MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV block | May 19, 2021 |
| Z-2144-2021 | Class II | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2148-2021 | Class II | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2145-2021 | Class II | FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2146-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2152-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2150-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker | May 19, 2021 |
| Z-2154-2021 | Class II | SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blo | May 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Bl | January 25, 2024 |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) | February 4, 2022 |
| K213164 | Avaira Vitality | October 26, 2021 |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilc | October 20, 2020 |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (St | March 23, 2020 |
| K190965 | MyDay | April 29, 2019 |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | December 11, 2018 |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | July 13, 2016 |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | December 23, 2013 |
| K131378 | SUS (STENFILCON A) CONTACT LENS | August 30, 2013 |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | May 30, 2013 |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | April 3, 2012 |
| K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TOR | December 21, 2011 |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | December 2, 2011 |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | December 2, 2011 |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | September 15, 2011 |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT | June 29, 2011 |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | January 5, 2010 |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | September 29, 2008 |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | January 4, 2008 |