Data / Medical devices / Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Instrument, Vitreous Aspiration And Cutting, Ac-Powered (HQE): 22 FDA-registered makers in 7 countries
22 establishments in 7 countries are registered with the FDA to make Instrument, Vitreous Aspiration And Cutting, Ac-Powered (product code HQE, Class 2, 21 CFR 886.4150). 11 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 149 510(k) clearances under this code, the latest on August 10, 2022, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HQE
- Device class
- 2
- Regulation
- 886.4150
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Switzerland | 3 |
| Mexico | 2 |
| Indonesia | 1 |
| China | 1 |
| Germany | 1 |
| Netherlands | 1 |
Makers of Instrument, Vitreous Aspiration And Cutting, Ac-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Instrument Development Laboratories, Inc. | San Leandro, CA, United States | Contract manufacturer, Manufacturer | 3 | April 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | April 29, 2016 | 0 | 3 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer, Repackager or relabeler | 2 | April 29, 2016 | 0 | 1 | 0 | api.fda.gov |
| Alcon Grieshaber AG | Schaffhausen, Switzerland | Manufacturer | 1 | August 22, 2014 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | August 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 1 | August 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 1 | August 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 1 | August 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer, Repackager or relabeler | 1 | April 29, 2002 | 0 | 0 | 0 | api.fda.gov |
| PT. Ciba Vision Batam | BATAM ISLAND Riau, Indonesia | Manufacturer | 1 | August 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Synergetics, Inc. | O Fallon, MO, United States | Manufacturer | 1 | February 23, 1994 | 0 | 1 | 0 | api.fda.gov |
| ABA Medical Technology Co Ltd | Guang dong Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | ZUIDLAND Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microsurgical Technology, Inc. | Redmond, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oertli Instrumente AG | BERNECK Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peregrine Surgical, LLC. | New Britain, PA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| This AG | Heerbrugg Sankt Gallen, Switzerland | Exporter to the US, 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 August 10, 2022. 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.