Cannula, Trocar, Ophthalmic
FDA adverse event reports and recall history for cannula, trocar, ophthalmic (product code NGY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 327
- Deaths
- 0
- Injuries
- 23
- Malfunctions
- 301
Reports per year
Source: FDA adverse event reports by year received, 2007–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-24Open, ClassifiedProcess control
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 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Due to incomplete seals in the pouch which provide the sterile barrier.
- 2023-04-26TerminatedProcess control
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.
A packaging defect may compromise the sterile barrier.
- 2016-05-18TerminatedProcess control
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.
The product has potential to leak beyond their design specification.
- 2016-05-18TerminatedProcess control
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.
The product has potential to leak beyond their design specification.
- 2016-05-18TerminatedProcess control
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) surgeries.
The product has potential to leak beyond their design specification.
- 2012-09-27TerminatedDevice Design
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 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
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 regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.
- 2009-05-26TerminatedProcess control
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
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.
- 2009-05-26TerminatedProcess control
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.
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.
- 2007-03-13TerminatedOther
19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.
- TerminatedUnknown/Undetermined by firm
MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use
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