Cannula, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
807 adverse event reports on file
- Alcon Microsurgical Instruments, Cannula OphthalmicJul 30, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00795
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 22, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00780
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 22, 2026InjuryAlcon Research, Llc - Alcon Precision Device2523835-2026-00781
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 17, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00763
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 13, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00730
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 4, 2026InjuryAlcon Research, Llc - Alcon Precision Device2523835-2026-00677
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJul 2, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00654
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJun 19, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00615
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJun 17, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00605
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICJun 11, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00590
Event type breakdown
Most-reported manufacturers
Recalls
28 recall events for this product code
- Iantrek Inc.Open, ClassifiedOct 10, 2025
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300.
Potential for compromised integrity of the sterile packaging.
Z-0134-2026 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedMar 14, 2024
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye
Pack and pouch label is missing the manufacturing and expiration date.
Z-1294-2024 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1626-2022 · View FDA record ↗ - Hill-Rom, Inc.TerminatedJun 19, 2015
Steriseal-Cannula Ophthalmic;
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Z-1820-2015 · View FDA record ↗ - Ellex iScience, Inc.TerminatedSep 4, 2014
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.
Z-2590-2014 · View FDA record ↗ - Beaver-Visitec International Inc.TerminatedMay 27, 2014
Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in)
Contains a sharp tip needle when the product should contain a blunt tip cannula
Z-1664-2014 · View FDA record ↗ - Synergetics IncTerminatedOct 22, 2013
Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25.
One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
Z-0051-2014 · View FDA record ↗ - Insight Instruments, Inc.TerminatedMay 10, 2013
Insight Instruments MIS ( Multi-Port Illumination System)
Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
Z-1281-2013 · View FDA record ↗ - Bausch and Lomb, IncorporatedTerminatedJan 17, 2013
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodi
Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidents, detachment has resulted in serious patient injury.
Z-0672-2013 · View FDA record ↗ - Becton Dickinson and CompanyTerminatedMay 10, 2011
BD Visitec
Restricted or no fluid flow for Visitec High Viscosity Injector.
Z-2159-2011 · View FDA record ↗
Registered firms
255 firms currently registered for this product code
D.o.r.c. Dutch Ophthalmic Research Center (international) B.v.
ZUIDLAND Zuid-Holland, NL
Nova Eye Inc.
Fremont, CA, US
Surgiscape
Sialkot Punjab, PK
Raico
Westmont, IL, US
Accutome, Inc.
Malvern, PA, US
Sterimedix Ltd.
REDDITCH Worcestershire, GB
Vitreq Bv
Vierpolders Zuid-Holland, NL
Holger Bumueller Llc
Rutherfordton, NC, US
Stephens Instruments, Inc
LEXINGTON, KY, US
Kdans Surgical Private Limited
GANDHINAGAR Gujarat, IN
Beaver-visitec International, Inc.
Waltham, MA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Daud Jee Mfg Co
Sialkot Punjab, PK
Fci Sas
BESANCON Doubs, FR
Oasis Medical, Inc.
Glendora, CA, US
Consolidated Medical Equipment Company
Chihuahua, MX
Indo-german Surgical Corporation
Mumbai Maharashtra, IN
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Inka Surgical Instruments
Jandakot Western Australia, AU
Teleflex Medical Llc
Morrisville, NC, US
Sterigenics U.s., Llc
Atlanta, GA, US
Surgimed Devices
AHMEDABAD Gujarat, IN
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
510(k) clearances
77 clearances for this product code
- Micron Surgical, Inc.May 2, 2001
K010305 · WEISS RETINAL CANNULA
- Retinalabs.ComMay 9, 2000
K000457 · VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
- American Medical Devices, Inc.May 20, 1997
K970873 · ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
- Pharma-Plast, Ltd.Jan 18, 1995
K943932 · STERISEAL OPHTHALMIC CANNULA
- Microsurgical Technology, Inc.Aug 17, 1994
K942403 · INFUSION CANNULA
- Microsurgical Technology, Inc.Apr 19, 1994
K934844 · INTER TIP T
- Kirwan Surgical Products, Inc.Feb 17, 1994
K930113 · KIRWAN IRRIGATION/ASPIRATION HANDPIECE
- Surgical Technologies, Inc.May 7, 1992
K921488 · ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION