Panels › Ophthalmic › Product code MLZ · Class 2
Vitrectomy, Instrument Cutter
Regulation 886.4150
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in MLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Alcon Research, Ltd. | 2 | 2 |
| Abbott Medical Optics Inc. (AMO) | 0 | 1 |
| Advanced Medical Optics, Inc. | 1 | 0 |
| Johnson & Johnson Surgical Vision Inc | 0 | 1 |
| Vista Ophthalmics, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UN Open, Classified |
MLZ | K141065 K233876 +1 |
| Jul 10, 2025 | Alcon Research LLC Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Vitrectomy Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Pr Open, Classified |
MLZ | K141065 |
| Sep 24, 2018 | Johnson & Johnson Surgical Vision Inc Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc.,
The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from Terminated |
MLZ | K081681 |
| May 16, 2017 | Abbott Medical Optics Inc. (AMO) AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use. Terminated |
MLZ | K081681 |
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