Medical device manufacturer
CooperVision, Inc.
CooperVision, Inc. holds 97 FDA 510(k) clearances across 29 product codes. Median elapsed review time is 72 days. openFDA lists 38 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 97
- Product codes
- 29
- Median review
- 72 days
- Recall records
- 38
How does FDA spell CooperVision, Inc.?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| COOPERVISION INC. | device/registrationlisting | normalised |
| COOPERVISION, INC. | device/registrationlisting | normalised |
| CooperVision Inc. | device/recall | normalised |
| CooperVision Inc. | device/enforcement | normalised |
| CooperVision Limited | device/registrationlisting | normalised |
| CooperVision, Inc. | device/510k | normalised |
| CooperVision, Inc. | device/recall | normalised |
| CooperVision, Inc. | device/registrationlisting | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does CooperVision, Inc. file in?
29 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 37 | 79 days | |
| HQC | Unit, Phacofragmentation | 15 | 91 days | |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 7 | 77 days | |
| HQF | Laser, Ophthalmic | 3 | 56 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 177 days | |
| HKX | Tonometer, Ac-Powered | 2 | 89 days | |
| HPX | Lens, Contact (Polymethylmethacrylate) | 2 | 27 days | |
| KYB | Lens, Guide, Intraocular | 2 | 24 days | |
| MVN | Lens, Contact, (Disposable) | 2 | 57 days | |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | 1 | 100 days | |
| ELC | Scaler, Ultrasonic | 1 | 71 days | |
| FXP | Cover, Shoe, Operating-Room | 1 | 43 days | |
| GDX | Scalpel, One-Piece | 1 | 23 days | |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 | 69 days | |
| GEX | Powered Laser Surgical Instrument | 1 | 218 days | |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 | 34 days | |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 | 45 days | |
| HMR | Marker, Ocular | 1 | 20 days | |
| HMT | Drape, Patient, Ophthalmic | 1 | 22 days | |
| HNL | Probe, Lachrymal | 1 | 84 days | |
| HNN | Knife, Ophthalmic | 1 | 108 days | |
| HNR | Forceps, Ophthalmic | 1 | 29 days | |
| HNY | Cystotome | 1 | 28 days | |
| HOE | Caliper, Ophthalmic | 1 | 17 days | |
| HOO | Perimeter, Ac-Powered | 1 | 42 days |
Showing the 25 they file in most, of 29.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has CooperVision, Inc. had a recall?
openFDA lists 38 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2606-2025Class IIOpen, ClassifiedMVN
One lot manufactured with an invalid sterilization cycle.
Z-2607-2025Class IIOpen, ClassifiedMVN
One lot manufactured with an invalid sterilization cycle.
Z-2608-2025Class IIOpen, ClassifiedMVN
One lot manufactured with an invalid sterilization cycle.
Z-2165-2025Class IIOpen, ClassifiedLPM
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Z-2166-2025Class IIOpen, ClassifiedLPM
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Showing the 5 most recently initiated of 38.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has CooperVision, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | LPL | 28 | |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | 25 | |
| K213164 | Avaira Vitality | LPL | 28 | |
| 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 | 29 | |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | LPL | 266 | |
| K190965 | MyDay | LPL | 17 | |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | LPL | 146 | |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | LPL | 112 | |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | LPL | 27 | |
| K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | 108 |
Source: openFDA device/510k · retrieved
Where is CooperVision, Inc. registered?
FDA lists 4 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what CooperVision, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.