Data / Medical devices / Unit, Phacofragmentation / United States
FDA-registered makers of Unit, Phacofragmentation in the United States: 28 establishments
28 establishments in the United States are registered with the FDA to make Unit, Phacofragmentation (product code HQC). 16 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Unit, Phacofragmentation
- Product code
- HQC
- Country
- United States
Makers of Unit, Phacofragmentation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 21 | March 25, 2026 | 0 | 3 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer, Repackager or relabeler | 19 | March 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 15 | March 12, 2021 | 0 | 4 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 6 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 6 | June 21, 2024 | 0 | 2 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer, Repackager or relabeler | 6 | March 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| AMO Manufacturing USA, LLC | Milpitas, CA, United States | Manufacturer, Specification developer | 5 | March 12, 2021 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 5 | June 21, 2024 | 0 | 1 | 0 | api.fda.gov |
| Carl Zeiss Meditec Cataract Technology Inc | Reno, NV, United States | Manufacturer | 4 | August 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 3 | January 10, 2024 | 0 | 1 | 0 | api.fda.gov |
| Medical Technical Products, Inc | Irvine, CA, United States | Manufacturer | 3 | September 22, 2008 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | January 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| LENSAR, Inc | Orlando, FL, United States | Manufacturer | 1 | December 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| Med-Logics, Inc. | Athens, TX, United States | Manufacturer | 1 | August 25, 1998 | 0 | 0 | 0 | api.fda.gov |
| Microsurgical Technology, Inc. | Redmond, WA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | October 13, 1994 | 0 | 0 | 0 | api.fda.gov |
| Raico | Westmont, IL, United States | Complaint file establishment, Specification developer | 1 | May 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Instrument Development Laboratories, Inc. | San Leandro, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo, Inc. | McMinnville, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peregrine Surgical, LLC. | New Britain, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saint-Gobain Performance Plastics | Portage, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergetics, Inc. | O Fallon, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Orchard Park, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zevex, Inc. | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 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.