CooperVision, Inc.
CooperVision, Inc. holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2024, with 33 FDA device recalls on record.
Top product codes for CooperVision, Inc.
FDA recalls by CooperVision, Inc.
10 most recent of 33- Z-2606-2025 — 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.
- Z-2608-2025 — 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 Disposable Wear. Blister packaged.
- Z-2607-2025 — 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 Wear. Blister packaged.
- Z-2165-2025 — Biofinity XR Toric Contact Lens
- Z-2166-2025 — Biofinity Toric Multifocal Contact Lens
- Z-1455-2025 — 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 Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No
- Z-3311-2024 — 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.
- Z-3310-2024 — 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.
- Z-1282-2023 — Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
- Z-1197-2023 — Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by CooperVision, Inc.
- K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
- K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
- K213164 — Avaira Vitality
- 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)
- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
- K190965 — MyDay
- K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
- K160803 — Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
- K133627 — AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
- K131378 — SUS (STENFILCON A) CONTACT LENS
- K123202 — PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
- K113759 — AVAIRA (ENFILCON A) CONTACT LENS
- K112302 — PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
- K113245 — AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
- K113267 — BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
- K111966 — PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
- K110099 — PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS
- K091339 — BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K081865 — PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
- K071736 — AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
- K061948 — PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
- K052560 — BIOFINITY (COMFILCON A) SOFT CONTACT LENS
- K050717 — PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
- K042824 — FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- K042435 — COOPER PROSTHETIC
- K041138 — LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
- K032873 — PROCLEAR COMPATIBLES MULTIFOCAL
- K020392 — FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
- K002625 — METHAFILCON A
- K001089 — POLYMACON
- K001090 — METHAFILCON A
- K000384 — FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
- K993252 — METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
- K990606 — TETRAFILCON A
- K980649 — PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS
- K963013 — PREFERENCE 60 AND PREFERENCE 60 TORIC
- K962185 — HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
- K954139 — AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
- K950968 — TETRAFILCON A HYDROPHILIC CONTACT LENSES
- K890635 — CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
- K890300 — INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
- K882372 — RESUBMITTED DIODE LASER COAGULATOR
- K881095 — KOI(TM) INSTRUMENT TRAYS
- K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132
- K872214 — COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
- K871854 — IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
- K871871 — SERIES TEN THOUSAND OCUTOME
- K871440 — KRATZ NOVA-SERT
- K870265 — KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
- K864336 — PACHYMETER SYSTEM V
- K862987 — MODEL 1000 OPHTHALMIC LASER SYSTEM
- K854653 — CILCO SONOMETRICS DIGICON
- K861380 — SERIES TEN THOUSAND MASTER
- K861565 — SERIES TEN THOUSAND COMPACT
- K861535 — OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
- K861141 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
- K854949 — MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
- K854375 — COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
- K853063 — SMARTKNIFE SYSTEM
- K853631 — POLY-SLEEVE
- K853070 — COOPER VISION SYSTEM VI U/S MODULE
- K852271 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
- K842781 — PERMALID PAK
- K842814 — PERMALID LINER PAK
- K851203 — R PAK
- K843915 — MINI-HALO CO2 LASER SYSTEM
- K850148 — KCP PAK CONVENIENCE PACK
- K850149 — KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
- K850275 — KCP PAK #2 CONVENIENCE PACK MODIFICATION
- K842757 — ULTRASCAN DIGITAL B
- K842945 — COOPERVISION SYSTEM VI
- K842979 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
- K843386 — MENDEZ U/S CYSTOTOME
- K840836 — CAT 100
- K840141 — DENTAL ULTRASONIC SCALER/ENDOSONIC
- K833465 — DISPOSABLE FIBER OPTIC ILLUMINATOR
- K833783 — DISPOS. I/A & IRRIGATION HANDPIECES
- K833784 — DISPOSABLE I/A HANDPIECE
- K833671 — STERILE OIL AND GUIDEWIRE
- K833371 — DISPOSABLE OCUTOME PROBE
- K833494 — CLERZ LUBRICATING/REWETTING SOLUTION
- K832800 — AUTOMATIC TANGENT SCREEN 50
- K832085 — LENSOMETER
- K832073 — ELECTRIC INSTRUMENT TABLE
- K832074 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
- K832142 — DICON GLAUCOMA DIAG. CENTER 2000 SERIES
- K831916 — DISPOSABLE CYSTOTOME
- K831836 — EPSILON ULTRASONIC TIP
- K830740 — CLERZ LUBRICATING & REWETTING EYE DROPS
- K830821 — MICRO-MITT
- K830822 — EYE DRAPE
- K830011 — VFS 1000/SCREENING FUNCTION ANALYZER
- K822220 — COOPER VISION I/A SYSTEM III MODEL 1500
- K820730 — MICRO CISE DIAMOND SCALPEL
- K812433 — LENSINE EXTRA STRENGTH CLEANER
- K812126 — ULTRASONIC TIPS
- K780872 — CYTOLOGY BRUSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.