Data / Medical devices / Lens, Contact (Polymethylmethacrylate)
Lens, Contact (Polymethylmethacrylate) (HPX): 9 FDA-registered makers in 2 countries
9 establishments in 2 countries are registered with the FDA to make Lens, Contact (Polymethylmethacrylate) (product code HPX, Class U). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 74 510(k) clearances under this code, the latest on May 16, 1996, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- HPX
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Canada | 2 |
Makers of Lens, Contact (Polymethylmethacrylate)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acuity Polymers Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | February 27, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Wilmington, MA, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Paragon Vision Sciences, Inc. | Gilbert, AZ, United States | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Art Optical Contact Lens, Inc. | Walker, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blanchard Vision Corp. | SHERBROOKE Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Lynchburg, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optik K & R Inc. | Toronto Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Cel Specialty Contacts | Duluth, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 16, 1996. 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.