Data / Medical devices / United States / Coopervision, Inc.
Coopervision, Inc.: FDA-registered device maker in Scottsville, NY, United States, 3 510(k) clearances and 2 PMA approvals
Coopervision, Inc. is registered with the FDA (registration 1314956) in Scottsville, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 30, 2013. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1314956
- Address
- 711 North RD., Scottsville, NY, United States, 14546
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 27, 2006
- Registered through
- 2026
- Brand names listed
- BIOFINITY MULTIFOCAL, BIOFINITY TORIC, BIOFINITY TORIC MULTIFOCAL, BIOFINITY XR, Biofinity, Biofinity Energys, Biofinity XR Multifocal, Biofinity XR Toric
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 30, 2013 | K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | 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 |
| November 7, 2003 | K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | LPL | Substantially Equivalent | CooperVision, 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 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 16, 2025 | 97173 | Class II | Ongoing | Biofinity XR Toric Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | accessdata.fda.gov |
| July 22, 2003 | 26795 | Not yet classified | Terminated | Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546. | Mislabeled with incorrect sphere power. | accessdata.fda.gov |
| June 25, 2003 | 26532 | Not yet classified | Terminated | 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, Hamble, SO31, 4RF, UK | The actual sphere power of the lens is lower than the labeled value. | 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 September 2, 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.