Data / Medical devices / Vitrectomy, Instrument Cutter
Vitrectomy, Instrument Cutter (MLZ): 16 FDA-registered makers in 3 countries
16 establishments in 3 countries are registered with the FDA to make Vitrectomy, Instrument Cutter (product code MLZ, Class 2, 21 CFR 886.4150). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on May 4, 2022, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MLZ
- Device class
- 2
- Regulation
- 886.4150
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Mexico | 4 |
| Switzerland | 2 |
Makers of Vitrectomy, Instrument Cutter
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 |
|---|---|---|---|---|---|---|---|---|
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 2 | March 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 2 | March 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 2 | March 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | October 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Vista Ophthalmics | Houston, TX, United States | Specification developer | 1 | May 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Alcon Grieshaber AG | Neuhausen Schaffhausen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Grieshaber AG | Schaffhausen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Irvine, CA, United States | 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 Cataract Technology Inc | Reno, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coastline de Mexico SA de CV | Tijuana Baja California, Mexico | 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 | |
| Manufacturas Y Servicios Internacionales, S. De R.L. | Cd Juarez Chihuahua, Mexico | 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 | |
| RM Healthcare Products SA de CV | JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 4, 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.