Panels › Ophthalmic › Product code NGY · Class 1
Cannula, Trocar, Ophthalmic
Regulation 886.4350
0510(k)s in 12 months (1 all time)
0recalls in 12 months (11 all time)
2recalls that name a 510(k)
Top companies in NGY
| Company | 510(k)s | Recalls |
|---|---|---|
| Alcon Research LLC | 0 | 6 |
| Mani, Inc. - Kiyohara Facility | 0 | 3 |
| Alcon Laboratories, Inc | 0 | 2 |
| Bausch & Lomb, Inc. | 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'
8065000356 27 Open, Classified |
NGY | None listed |
| Apr 26, 2023 | Mani, Inc. - Kiyohara Facility Mani Trocar Kit, Model MTK23S and Model MTK25S
There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula. Terminated |
NGY | None listed |
| Oct 27, 2020 | Mani, Inc. - Kiyohara Facility MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S Terminated |
NGY | None listed |
| Oct 27, 2020 | Mani, Inc. - Kiyohara Facility MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S Terminated |
NGY | None listed |
| May 18, 2016 | Alcon Research, Ltd. Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surge Terminated |
NGY | None listed |
| May 18, 2016 | Alcon Research, Ltd. 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. Terminated |
NGY | None listed |
| May 18, 2016 | Alcon Research, Ltd. Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. Terminated |
NGY | None listed |
| Sep 27, 2012 | Alcon Research, LTD. This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus Terminated |
NGY | None listed |
| May 26, 2009 | Alcon Laboratories, Inc Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | K880961 |
| May 26, 2009 | Alcon Laboratories, Inc Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | K911808 |
| Mar 13, 2007 | Alcon Research, Ltd 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203. Terminated |
NGY | None listed |
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