Home › Device types › NGY
Cannula, Trocar, Ophthalmic
FDA product code NGY · Class 1 · Ophthalmic
109
Registered devices
371
Adverse events
11
Recalls
1
510(k) clearances
Devices with this code
Trocar set 20G with removable valve — AKTIVE SRLRumex — RUMEX INTERNATIONAL CORP.Disposable one step single cannula including inserter. (25 gauge / 0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Reusable universal cannula.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Closure valves for 20 gauge/0.9 mm cannula system. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.UNITY — Alcon Laboratories, Inc.Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Trocar 27G with removable valve — AKTIVE SRLMANI Trocar Kit — MANI, INC.ALCON — Alcon Laboratories, Inc.Closure valves for 23 gauge/0.6 mm vitrectomy system. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.WELL-LIFE — WELL-LIFE HEALTHCARE LTD.Trocar set 27g with removable valve — AKTIVE SRLN/A — MICROVISION, INC.N/A — MICROVISION, INC.ALCON — Alcon Laboratories, Inc.MANI Trocar — MANI, INC.Disposable One step Cannula System.(27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.25G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.23G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MANI Infusion Cannula — MANI, INC.27G Single Trocar — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MANI Infusion Cannula — MANI, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-05 | Alcon Research LLC | Due to incomplete seals in the pouch which provide the sterile barrier. |
| 2023-02-20 | Mani, Inc. - Kiyohara Facility | A packaging defect may compromise the sterile barrier. |
| 2020-10-27 | Mani, Inc. - Kiyohara Facility | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| 2020-10-27 | Mani, Inc. - Kiyohara Facility | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2015-08-11 | Alcon Research, Ltd. | The product has potential to leak beyond their design specification. |
| 2012-05-29 | Alcon Research, LTD. | This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regar |
| 2009-04-29 | Alcon Laboratories, Inc | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
| 2009-04-29 | Alcon Laboratories, Inc | Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades. |
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