ClearanceBrief
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)
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Top companies in NGY

DateFirm and productCodeLinked 510(k)
Oct 24, 2025Alcon 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
NGYNone listed
Apr 26, 2023Mani, 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
NGYNone listed
Oct 27, 2020Mani, 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
NGYNone listed
Oct 27, 2020Mani, 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
NGYNone listed
May 18, 2016Alcon 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
NGYNone listed
May 18, 2016Alcon 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
NGYNone listed
May 18, 2016Alcon 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
NGYNone listed
Sep 27, 2012Alcon 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
NGYNone listed
May 26, 2009Alcon 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
NGYK880961
May 26, 2009Alcon 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
NGYK911808
Mar 13, 2007Alcon Research, Ltd
19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
Terminated
NGYNone listed

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