Cannula, Ophthalmic
FDA product code HMX · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic
77510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Advanced Surgical Products, Inc. 29
- Microsurgical Technology, Inc. 6
- Look, Inc. 5
- Visitec Co. 3
- Van Dellen, Ltd. 2
- Myocure, Inc. 2
- Storz Instrument Co. 2
- Optical Micro Systems, Inc. 1
- Design Research Assoc., Inc. 1
- Medical Instrument Development Laboratories, Inc. 1
- Dey Laboratories, Inc. 1
- Koi, Inc. 1
- Chiron Vision Corp. 1
- Micron Surgical, Inc. 1
- American V. Mueller 1
- Tridak Division of Indicon, Inc. 1
- Rophae Lens Co., Inc. 1
- Cooper Medical Devices Corp. 1
- Contemporary Surgical Systems, Inc. 1
- Edward Weck, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | Retinalabs.Com | 05/09/2000SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K930113 | Kirwan Irrigation/Aspiration HandpieceHMX · Traditional | Kirwan Surgical Products, Inc. | 02/17/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
| K901618 | Ocular Infusion Cannula SystemHMX · Traditional | Tamcenan Corp. | 05/31/1990SE |
| K890782 | Grieshaber Soft Tip Needle (20 & 19 Gauges)HMX · Traditional | Grieshaber & Co. | 06/23/1989SE |
| K882884 | Storz Infusion CannulaHMX · Traditional | Storz Instrument Co. | 08/04/1988SE |
| K880347 | Anesthesia/Retrobulbar NeedlesHMX · Traditional | Myocure, Inc. | 05/03/1988SE |
| K880346 | CannulasHMX · Traditional | Myocure, Inc. | 05/03/1988SE |
| K875030 | OCU-1HMX · Traditional | Rudolph Beaver, Inc. | 05/03/1988SE |
| K881487 | Ophthalmic CannulaHMX · Traditional | Surgical Instrument, Inc. | 04/29/1988SE |
| K875003 | Prisma Disposable Pupil Centering CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K875002 | Prisma Disposable Viscoelastic I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874999 | Prisma Disposable Atkinson Retrobulbar NeedleHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874998 | Prisma Disposable U-Shaped CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874996 | Prisma Disposable Kuglen Irrigating Lens Manipula.HMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874995 | Prisma Dispos. Curved Lachrymal CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874994 | Prisma Disposable Angled I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874992 | Prisma Disposable Irrigating Lens DialerHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874990 | Prisma Disposable Silicone BulbHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874989 | Prisma Disposable Adapter for IrrigatorsHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874988 | Prisma Dispos. Pearce Irrigating Vectus W/One PortHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874987 | Prisma Disposable Double I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874986 | Prisma Disposable Retrobulbar NeedleHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874985 | Prisma Disposable Capsule PolisherHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874984 | Prisma Disposable Micro Irrigating VectusHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874982 | Prisma Disposable Simcoe ExtractorHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874981 | Prisma Disposable J-Shaped I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874980 | Prisma Disposable Lewicky Chamber MaintainerHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874978 | Prisma Disposa. Rycroft Anterior Chamber CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874977 | Prisma Disposable Double I/A Cannula ClosedHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874974 | Prisma Disposable Simcoe Capsule PolisherHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874973 | Prisma Disposable Simcoe I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874972 | Prisma Dispos. Bishop-Harmon Irrigating CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874971 | Prisma Disposable Pearce Irrigating VectusHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874970 | Prisma Dispos. Troutman Alpha-Chymotrypsin CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874969 | Prisma Disposable Kratz Capsule PolisherHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874968 | Prisma Disposable Gills Angled I/A CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K873853 | Disposable Infusion Cannula 0045-1/2/3 2.5/4.0/6.0HMX · Traditional | Advanced Surgical Products, Inc. | 03/07/1988SE |
| K873164 | Van Dellen Healon CannulaHMX · Traditional | Van Dellen, Ltd. | 09/04/1987SE |
| K873162 | Van Dellen Retrobulbar NeedleHMX · Traditional | Van Dellen, Ltd. | 09/04/1987SE |
| K872884 | Look Irrigating/Aspirating Cannula W/Teflon SheathHMX · Traditional | Look, Inc. | 08/10/1987SE |
| K872610 | Solos Eyesite CannulasHMX · Traditional | Solos Ophthalmology | 07/31/1987SE |
| K872200 | Hamacher Bullet Point Ophthalmic NeedleHMX · Traditional | R. J. Doyle, Inc. | 06/25/1987SE |
| K872151 | Ophthalmic CannulaHMX · Traditional | Pharmacia, Inc. | 06/19/1987SE |
| K871605 | MVS 2.5MM, 4.0MM, 6.0MM Infusion CannulaHMX · Traditional | Advanced Surgical Products, Inc. | 06/19/1987SE |
| K870902 | Look Retrobulbar NeedlesHMX · Traditional | Look, Inc. | 03/20/1987SE |
| K870441 | Look Cortex ExtractorsHMX · Traditional | Look, Inc. | 02/20/1987SE |
| K870438 | Look Irrigating CannulasHMX · Traditional | Look, Inc. | 02/20/1987SE |
| K870436 | Look Irrigating/Aspirating CannulasHMX · Traditional | Look, Inc. | 02/20/1987SE |
| K861545 | Irrigation/Aspiration Cannulas, Various SizesHMX · Traditional | Rophae Lens Co., Inc. | 05/28/1986SE |
| K860744 | Opthalmic Surgical InstrumentsHMX · Traditional | Tridak Division of Indicon, Inc. | 03/31/1986SE |
| K854506 | Storz MVS 2.5MM/4.0MM,6.0MM Infusion CannulaHMX · Traditional | Storz Instrument Co. | 02/07/1986SE |
| K854402 | The New Mcintyre I.A. HandpieceHMX · Traditional | Microsurgical Technology, Inc. | 12/30/1985SE |
| K854401 | The New Mobile Tip Mcintyre CannulaHMX · Traditional | Microsurgical Technology, Inc. | 12/30/1985SE |
| K853777 | The New Mcintyre CannulaHMX · Traditional | Microsurgical Technology, Inc. | 11/21/1985SE |
| K852758 | Infusion CannulamHMX · Traditional | Precision Medical Instruments, Inc. | 08/01/1985SE |
| K843039 | Site Anterior CapsulotomerHMX · Traditional | Chiron Vision Corp. | 11/21/1984SE |
| K840442 | Sterilized Dispos. CystotomeHMX · Traditional | Microsurgical Technology, Inc. | 03/16/1984SE |
| K831532 | Ocular Irrigating CannulaHMX · Traditional | Dey Laboratories, Inc. | 07/12/1983SE |
| K831192 | Infusion CannulaHMX · Traditional | Medical Instrument Development Laboratories, Inc. | 06/30/1983SE |
| K813314 | NLD Implant SetHMX · Traditional | Design Research Assoc., Inc. | 02/24/1982SE |
| K813481 | Oms Infusion Cannula AssembleHMX · Traditional | Optical Micro Systems, Inc. | 01/22/1982SE |
| K812010 | Koi Lacrimal Intubation SystemHMX · Traditional | Koi, Inc. | 07/28/1981SE |
| K811455 | Anis Guiding CannulaHMX · Traditional | American V. Mueller | 06/16/1981SE |
| K801411 | May Illuminated/Infusion PicHMX · Traditional | Cooper Medical Devices Corp. | 07/21/1980SE |
| K791917 | X-PakHMX · Traditional | Contemporary Surgical Systems, Inc. | 10/30/1979SE |
| K791982 | Cannula's Cat #'S 6636, 6624, 6625HMX · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K782169 | Needles, Cannulas, CystotomesHMX · Traditional | Visitec Co. | 02/13/1979SE |
| K790243 | CannulasHMX · Traditional | Visitec Co. | 02/12/1979SE |
| K771416 | Irrigation/Aspiration NeedleHMX · Traditional | Concept, Inc. | 09/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0134-2026 Class II | Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product…Potential for compromised integrity of the sterile packaging. | Iantrek Inc. | 09/06/2025Open, Classified |
| Z-1294-2024 Class II | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation…Pack and pouch label is missing the manufacturing and expiration date. | Beaver Visitec International, Inc. | 02/02/2024Open, Classified |
| Z-1626-2022 Class II | BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1852-2021 Class II | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF…The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. | Anodyne Surgical | 04/21/2021Terminated |
| Z-2091-2021 Class II | Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal…Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead… | Dutch Ophthalmic USA, Inc. | 02/25/2021Terminated |
| Z-0856-2020 Class II | VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0855-2020 Class II | VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0854-2020 Class II | VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0853-2020 Class II | VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0852-2020 Class II | VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-0851-2020 Class II | VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423Microscopic tears of the sterile pouch may compromise sterility | Vitreq Bv | 12/17/2019Terminated |
| Z-1066-2019 Class II | BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula…Certain lots are missing a protective sheath component over the silicone tip, which may result in the… | Beaver Visitec | 11/30/2018Terminated |
| Z-0011-2019 Class II | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF…Sterility failure found in one of the units in the lot. | Ellex iScience, Inc. | 01/11/2018Terminated |
| Z-1820-2015 Class II | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. | Hill-Rom, Inc. | 03/02/2015Terminated |
| Z-2590-2014 Class II | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.…One lot may not have been properly sealed, resulting in a non-sterile device. | Ellex iScience, Inc. | 08/06/2014Terminated |
| Z-1664-2014 Class II | Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended…Contains a sharp tip needle when the product should contain a blunt tip cannula | Beaver-Visitec International Inc. | 05/06/2014Terminated |
| Z-0051-2014 Class II | Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number:…One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is… | Synergetics Inc | 07/30/2013Terminated |
| Z-1281-2013 Class II | Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work…Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic… | Insight Instruments, Inc. | 03/15/2013Terminated |
| Z-0672-2013 Class I | Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium…Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not… | Bausch and Lomb, Incorporated | 11/15/2012Terminated |
| Z-2164-2011 | S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-2163-2011 | S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-2162-2011 | BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-2161-2011 | BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-2160-2011 | BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-2159-2011 | BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. | Becton Dickinson and Company | 12/17/2010Terminated |
| Z-0022-2009 | BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for…Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip. | Becton Dickinson and Company | 09/15/2008Terminated |
| Z-1197-2007 | Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The…Mislabeled: boxes actually contained Tri-Fact needles | Alcon Research, Ltd | 07/11/2007Terminated |