Device, Irrigation, Ocular Surgery
FDA product code KYG · Class I (low risk) · 21 CFR 886.4360 · Ophthalmic
40510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Visitec Co. 3
- Optical Micro Systems, Inc. 2
- Med-Logics, Inc. 2
- Mortan, Inc. 2
- Jedmed Instrument Co. 2
- Site Microsurgical Systems, Inc. 2
- Surgeon Surgical Instrumentation, Inc. 2
- B&B Medical Assoc., Inc. 2
- Staar Surgical Co. 1
- Retinalabs.Com 1
- Chiron Vision Corp. 1
- O.R. Specialties, Inc. 1
- Grieshaber & Co. 1
- Alcon Laboratories 1
- Nagle Co. 1
- Ameritek, Inc. 1
- Electro-Catheter Corp. 1
- Mid Laboratories, Inc. 1
- Innovative Surgical Products, Inc. 1
- General Medical Engineering Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010353 | Med-Logics Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 04/27/2001SE |
| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | Retinalabs.Com | 12/22/2000SE |
| K993591 | Bladeworks Disposable Alk TubingKYG · Traditional | Blade Works, Inc. | 12/28/1999SE |
| K981116 | Sovereign Cataract Extraction SystemKYG · Traditional | Allergan, Inc. | 05/19/1998SE |
| K980647 | Eye Irrigator Model #2020KYG · Traditional | Eye-Deal Ocular Safety Products, Inc. | 05/15/1998SE |
| K974561 | Moistair Fluid Air Tubing SetKYG · Traditional | American Medical Devices, Inc. | 02/19/1998SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 05/22/1997SE |
| K970161 | Hedges Corneal Wetting PakKYG · Traditional | Hedges Cwp, Inc. | 03/25/1997SE |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
| K940392 | Peregrine Pic MinipulatorKYG · Traditional | Peregrine Surgical , Ltd. | 08/23/1994SE |
| K935226 | I/V PoleKYG · Traditional | Optical Micro Systems, Inc. | 02/16/1994SE |
| K935003 | Electric I/V Pole or EIVP2KYG · Traditional | Optical Micro Systems, Inc. | 01/25/1994SE |
| K925921 | Modified Site Disposable Diaphragm CassetteKYG · Traditional | Site Microsurgical Systems, Inc. | 12/06/1993SE |
| K924999 | Autopole Regulator SystemKYG · Traditional | Escalon Trek Medical | 12/24/1992SE |
| K924052 | Infinity Micro IrrigatorKYG · Traditional | Infinity Surgical Technology, Inc. | 12/23/1992SE |
| K922996 | Modified Site Diaphragm Cassette for OphthalmicsKYG · Traditional | Chiron Vision Corp. | 07/27/1992SE |
| K922180 | Lewicky O.R.S. TubingKYG · Traditional | O.R. Specialties, Inc. | 07/02/1992SE |
| K915808 | Aqueous Paracentesis PipetKYG · Traditional | Visitec Co. | 03/19/1992SE |
| K914587 | Grieshaber Air/Fluid Tubing SetKYG · Traditional | Grieshaber & Co. | 01/23/1992SE |
| K904186 | Site Diaphragm CassetteKYG · Traditional | Site Microsurgical Systems, Inc. | 11/21/1990SE |
| K881518 | Infusion HandleKYG · Traditional | B&B Medical Assoc., Inc. | 08/22/1988SE |
| K881517 | B & B I/A HandpieceKYG · Traditional | B&B Medical Assoc., Inc. | 08/22/1988SE |
| K881682 | Alcon Site(R)-Compatible CassetteKYG · Traditional | Alcon Laboratories | 07/01/1988SE |
| K880543 | Uni-PortKYG · Traditional | Surgeon Surgical Instrumentation, Inc. | 07/01/1988SE |
| K871454 | Morgan Therapeutic LensKYG · Traditional | Mortan, Inc. | 06/19/1987SE |
| K861203 | Multi-SpikeKYG · Traditional | Surgeon Surgical Instrumentation, Inc. | 04/28/1986SE |
| K860544 | Bacstop Filter Irrigation Supply KitKYG · Traditional | Staar Surgical Co. | 04/04/1986SE |
| K861013 | Electrically Controlled I.V. Pole (Opthalmic)KYG · Traditional | Ameritek, Inc. | 03/31/1986SE |
| K853243 | Visitec Irrigation Control SystemKYG · Traditional | Visitec Co. | 09/11/1985SE |
| K845039 | Operaid Dispos. Irrigating KnifeKYG · Traditional | Jedmed Instrument Co. | 03/05/1985SE |
| K841807 | Operaid NucleusKYG · Traditional | Jedmed Instrument Co. | 11/21/1984SE |
| K832787 | Elecath Heparin Coated Thermal DilutionKYG · Traditional | Electro-Catheter Corp. | 10/04/1983SE |
| K831996 | Micro Surgical HandleKYG · Traditional | Visitec Co. | 07/12/1983SE |
| K821897 | LensKYG · Traditional | Mortan, Inc. | 01/05/1983SE |
| K820889 | Aspirator/Irrigator or I/A UnitKYG · Traditional | Mid Laboratories, Inc. | 05/05/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | Innovative Surgical Products, Inc. | 04/09/1982SE |
| K802332 | IntrajectKYG · Traditional | General Medical Engineering Corp. | 12/22/1980SE |
| K801822 | Nu-Vision Disp. Ophthalmic Dressing TrayKYG · Traditional | Summit Optics, Inc. | 09/30/1980SE |
| K760820 | Nalgene Emergency Eye WashKYG · Traditional | Nagle Co. | 10/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0130-2024 Class II | AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase… | B. Braun Medical, Inc. | 09/26/2023Open, Classified |
| Z-2221-2010 | BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope…Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in… | Insight Instruments, Inc. | 05/12/2010Terminated |
| Z-2220-2010 | CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured…Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in… | Insight Instruments, Inc. | 05/12/2010Terminated |
| Z-0742-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable…Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic… | Oasis Medical Inc | 04/09/2007Terminated |
| Z-0741-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable…Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic… | Oasis Medical Inc | 04/09/2007Terminated |
| Z-0740-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable…Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic… | Oasis Medical Inc | 04/09/2007Terminated |
| Z-0672-2007 | BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617… | Becton Dickinson and Company | 03/02/2007Terminated |