Vitrectomy, Instrument Cutter
FDA product code MLZ · Class II (moderate risk) · 21 CFR 886.4150 · Ophthalmic
4510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220030 | Vista Ophthalmics Vitrectomy ProbeMLZ · Traditional | Vista Ophthalmics, LLC | 05/04/2022SE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | Alcon Research, Ltd. | 03/22/2017SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | Alcon Research, Ltd. | 04/02/2010SE |
| K081681 | Vitrectomy Cutter and AccessoriesMLZ · Abbreviated | Advanced Medical Optics, Inc. | 10/08/2008SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0304-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | Alcon Research LLC | 08/05/2025Open, Classified |
| Z-2108-2025 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System…Due to the potential that some units within specific lots were damaged during the manufacturing process. The… | Alcon Research LLC | 04/28/2025Open, Classified |
| Z-1893-2019 Class II | Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The…Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a… | Johnson & Johnson Surgical Vision Inc | 09/24/2018Terminated |
| Z-2096-2017 Class II | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and…Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be… | Abbott Medical Optics Inc. (AMO) | 03/30/2017Terminated |