Instrument, Vitreous Aspiration And Cutting, Ac-powered
Ophthalmic · 21 CFR 886.4150
Recent MDR events
5,942 adverse event reports on file
- HyperVit Vitrectomy ProbeJul 31, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04097
- Backflush Handle DSPJul 31, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00161
- HyperVit Vitrectomy ProbeJul 28, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04043
- Backflush Handle DSPJul 27, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00156
- HyperVit Vitrectomy ProbeJul 27, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-04008
- Backflush Handle DSPJul 27, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00158
- HYPERVIT VITRECTOMY PROBEJul 22, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-03937
- HYPERVIT VITRECTOMY PROBEJul 22, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-03936
- HYPERVIT VITRECTOMY PROBEJul 22, 2026MalfunctionAlcon Research, Llc - Houston1644019-2026-03945
- LASER PROBESJul 22, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01129
Event type breakdown
Most-reported manufacturers
Recalls
37 recall events for this product code
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Open, ClassifiedJun 5, 2026
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Z-2322-2026 · View FDA record ↗ - D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Open, ClassifiedJun 5, 2026
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Z-2323-2026 · View FDA record ↗ - D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Open, ClassifiedJun 5, 2026
TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Z-2324-2026 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedOct 24, 2025
Brand Name: Alcon Laboratories, Inc.
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0306-2026 · View FDA record ↗ - Synergetics IncTerminatedOct 18, 2016
25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Z-0119-2017 · View FDA record ↗ - Synergetics IncTerminatedOct 18, 2016
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Z-0120-2017 · View FDA record ↗ - Synergetics IncTerminatedOct 18, 2016
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barri
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Z-0121-2017 · View FDA record ↗ - Synergetics IncTerminatedOct 18, 2016
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Z-0122-2017 · View FDA record ↗ - Alcon Grieshaber AGTerminatedJun 6, 2013
The Constellation Vision System Pneumatic Handpiece.
Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.
Z-1506-2013 · View FDA record ↗ - Bausch & Lomb IncTerminatedMay 28, 2010
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester,
Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
Z-1712-2010 · View FDA record ↗
Registered firms
135 firms currently registered for this product code
Bausch & Lomb Incorporated
Rochester, NY, US
This Ag
Heerbrugg Sankt Gallen, CH
Sterigenics U.s. Llc
Hayward, CA, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Zevex, Inc.
Salt Lake City, UT, US
Bausch & Lomb Incorporated
Manchester, MO, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
GROVEPORT, OH, US
Peregrine Surgical, Llc.
New Britain, PA, US
Alcon Research, Llc
IRVINE, CA, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Pt. Ciba Vision Batam
BATAM ISLAND Riau, ID
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Synergy Health Ede Bv
Venlo Limburg, NL
Isomedix Operations Inc.
SPARTANBURG, SC, US
510(k) clearances
149 clearances for this product code
- Visioncare Devices, LLCAug 10, 2022
K212763 · UniVit HE, UniVit UHS
- A.R.C Laser GmbHSep 27, 2017
K170183 · Cetus system, Cetus probe
- Medical Instrument Development LaboratoriesApr 29, 2016
K153168 · Bi-Blade Vitrectomy Cutter
- Alcon Research, Ltd.Aug 22, 2014
K141065 · CONSTELLATION VISION SYSTEM
- Synergetics, Inc.Jun 21, 2012
K121675 · VERSAVIT
- Visioncare Devices, Inc.May 30, 2012
K120170 · PROCARE PLUS VITRECTOMY SYSTEM
- Medical Instrument Development Laboratories, Inc.Apr 8, 2011
K102222 · ULTIMATE VIT ENHAMCER (UVE)
- Microworld Medical Instruments, Inc.Nov 4, 2003
K033390 · COLIBRI DISPOSABLE VITRECTOMY CUTTER