Company ยท US
CooperVision, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2024. Name variants (Inc, Corp, punctuation) are merged.
97510(k) clearances (0 in 12 months)
40recalls (2 in 12 months)
31recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 56 |
| HQC | Unit, Phacofragmentation | 15 |
| MVN | Lens, Contact, (Disposable) | 14 |
| LPM | Lenses, Soft Contact, Extended Wear | 9 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 7 |
| HQF | Laser, Ophthalmic | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 |
| HKX | Tonometer, Ac-Powered | 2 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 |
| KYB | Lens, Guide, Intraocular | 2 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 1 |
| ELC | Scaler, Ultrasonic | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| GDX | Scalpel, One-Piece | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 |
| HMR | Marker, Ocular | 1 |
| HMT | Drape, Patient, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2024 | K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker CooperVision, Inc. | LPL |
| Feb 4, 2022 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) CooperVision, Inc. | LPL |
| Oct 26, 2021 | K213164 | Avaira Vitality CooperVision, Inc. | LPL |
| Oct 20, 2020 | K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day CooperVision, Inc. | LPL |
| Mar 23, 2020 | K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOC CooperVision, Inc. | LPL |
| Apr 29, 2019 | K190965 | MyDay CooperVision, Inc. | LPL |
| Dec 11, 2018 | K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc. | LPL |
| Jul 13, 2016 | K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc. | LPL |
| Dec 23, 2013 | K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS CooperVision, Inc. | LPL |
| Aug 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS CooperVision, Inc. | LPL |
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS CooperVision, Inc. | LPL |
| Apr 3, 2012 | K113759 | AVAIRA (ENFILCON A) CONTACT LENS CooperVision, Inc. | LPL |
| Dec 21, 2011 | K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES CooperVision, Inc. | LPL |
| Dec 2, 2011 | K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC CooperVision, Inc. | LPL |
| Dec 2, 2011 | K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL CooperVision, Inc. | LPL |
| Sep 15, 2011 | K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC CooperVision, Inc. | LPL |
| Jun 29, 2011 | K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT CooperVision, Inc. | LPL |
| Jan 5, 2010 | K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc. | LPL |
| Sep 29, 2008 | K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR CooperVision, Inc. | LPL |
| Jan 4, 2008 | K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc. | LPL |
| Nov 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS CooperVision, Inc. | MVN |
| Dec 6, 2005 | K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS CooperVision, Inc. | LPL |
| May 13, 2005 | K050717 | PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC CooperVision, Inc. | LPL |
| Nov 16, 2004 | K042824 | FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc. | LPL |
| Oct 26, 2004 | K042435 | COOPER PROSTHETIC CooperVision, Inc. | LPL |
| Jul 23, 2004 | K041138 | LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS CooperVision, Inc. | LPL |
| Nov 7, 2003 | K032873 | PROCLEAR COMPATIBLES MULTIFOCAL CooperVision, Inc. | LPL |
| Apr 26, 2002 | K020392 | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR CooperVision, Inc. | LPL |
| Sep 13, 2000 | K002625 | METHAFILCON A CooperVision, Inc. | LPL |
| May 19, 2000 | K001090 | METHAFILCON A CooperVision, Inc. | LPL |
| May 19, 2000 | K001089 | POLYMACON CooperVision, Inc. | LPL |
| Mar 6, 2000 | K000384 | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX CooperVision, Inc. | LPL |
| Nov 24, 1999 | K993252 | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP CooperVision, Inc. | MVN |
| Mar 15, 1999 | K990606 | TETRAFILCON A CooperVision, Inc. | LPL |
| May 13, 1998 | K980649 | PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS CooperVision, Inc. | LPL |
| Dec 19, 1997 | K963013 | PREFERENCE 60 AND PREFERENCE 60 TORIC CooperVision, Inc. | LPL |
| Dec 17, 1996 | K962185 | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS CooperVision, Inc. | LPL |
| Nov 24, 1995 | K954139 | AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS CooperVision, Inc. | LPL |
| Jul 25, 1995 | K950968 | TETRAFILCON A HYDROPHILIC CONTACT LENSES CooperVision, Inc. | LPL |
| May 9, 1989 | K890635 | CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV. CooperVision, Inc. | HQC |
| Apr 17, 1989 | K890300 | INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE CooperVision, Inc. | HQE |
| Aug 2, 1988 | K882372 | RESUBMITTED DIODE LASER COAGULATOR CooperVision, Inc. | HQF |
| Apr 6, 1988 | K881095 | KOI(TM) INSTRUMENT TRAYS CooperVision, Inc. | LRP |
| Apr 1, 1988 | K881094 | KOI(TM) BLADE GAUGE, MODEL KOI-132 CooperVision, Inc. | HOE |
| Aug 17, 1987 | K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS CooperVision, Inc. | GEA |
| Jul 27, 1987 | K871854 | IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS CooperVision, Inc. | HQC |
| Jun 11, 1987 | K871871 | SERIES TEN THOUSAND OCUTOME CooperVision, Inc. | HQE |
| May 7, 1987 | K871440 | KRATZ NOVA-SERT CooperVision, Inc. | KYB |
| Feb 20, 1987 | K870265 | KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR CooperVision, Inc. | KYB |
| Jan 9, 1987 | K864336 | PACHYMETER SYSTEM V CooperVision, Inc. | IYO |
Newest 50 of 97.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | CooperVision, Inc. 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, Open, Classified |
LPL | K160803 K213164 +1 |
| Sep 18, 2026 | CooperVision, Inc. Brand Name: Pearle Vision 1 day
Product Name: (somofilcon A) Contact Lens
Model/Catalog Number: Pearle Vision 1 day Open, Classified |
MVN | K130331 |
| Sep 19, 2025 | CooperVision, Inc. 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 Open, Classified |
MVN | K131378 K190965 +1 |
| Sep 19, 2025 | CooperVision, Inc. 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 Wea Open, Classified |
MVN | K131378 K190965 +1 |
| Sep 19, 2025 | CooperVision, Inc. 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. Blist Open, Classified |
MVN | K131378 K190965 +1 |
| Jul 23, 2025 | CooperVision, Inc. Biofinity Toric Multifocal Contact Lens Open, Classified |
LPM | None listed |
| Jul 23, 2025 | CooperVision, Inc. Biofinity XR Toric Contact Lens Open, Classified |
LPM | None listed |
| Mar 26, 2025 | CooperVision, Inc. 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, Voy Open, Classified |
MVN | K131378 K190965 +1 |
| Sep 30, 2024 | CooperVision, Inc. 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. Open, Classified |
LPM | None listed |
| Sep 30, 2024 | CooperVision, Inc. 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. Open, Classified |
LPM | None listed |
| Mar 23, 2023 | CooperVision, Inc. Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 Open, Classified |
LPL | K181920 |
| Mar 1, 2023 | CooperVision, Inc. Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) Open, Classified |
LPM | None listed |
| Mar 1, 2023 | CooperVision, Inc. Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Open, Classified |
LPM | None listed |
| Jan 24, 2023 | CooperVision, Inc. MyDay Toric (90-pack)
Reveal 1 Day Toric (90-pack)
Soft (hydrophilic) Contact Lens (daily wear). Single Use. Open, Classified |
LPL | K131378 |
| May 19, 2021 | CooperVision Inc. SOFMED
BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.25/010
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. MEDIFLEX ELITE 1 DAY TORIC
Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC -DIAGNOSTIC
Power-07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. SPECSAVERS UMERE TORIC Power -07.00 -1.25/180
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.25/180
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power: -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | K130331 |
| Jan 27, 2020 | CooperVision Inc. Coopervision Vertex Toric /2 Clear Toric-
Power +2.25 -0.75/120
Soft (hydrophilic) Contact Lens (extended wear) Terminated |
LPM | None listed |
| Jan 27, 2020 | CooperVision Inc. Coopervision Vertex Toric /2 Clear Toric-
Power -2.50 -0.75 /90
Soft (hydrophilic) Contact Lens (extended wear) Terminated |
LPM | None listed |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. 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 b Terminated |
MVN | K130331 |
| Sep 1, 2017 | CooperVision Inc. 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 astigmati Terminated |
LPM | K052560 |
| Dec 19, 2013 | CooperVision Inc. ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 Terminated |
MVN | K091339 |
| Dec 19, 2013 | CooperVision Inc. 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 us Terminated |
MVN | K061948 |
| Jan 11, 2012 | Coopervision Inc. AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- CooperVision: Hamble, SO31 4RF, UK -- Scottsville, NY 14546 USA -- Juana Diaz, PR 00 Terminated |
LPL | K071736 |
| Oct 14, 2011 | CooperVision Inc. 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; Devi Terminated |
LPL | K071736 |
| Nov 9, 2009 | CooperVision Inc. 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 len Terminated |
MVN | None listed |
| Aug 7, 2003 | Coopervision Inc Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546. Terminated |
LPL | K962185 |
| Jul 3, 2003 | Coopervision Inc SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A)
and (2) ONEVUE 55 toric (methafilcon A) flexible wear.
Responsible firm on label: Coopervision, Terminated |
LPL | K973063 |