Forceps, Ophthalmic
FDA product code HNR · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic
44510(k) clearances
0PMA approvals
16recalls
Manufacturers
- Edward Weck, Inc. 14
- Storz Instrument Co. 2
- Alcon Laboratories 2
- Western Medical Products, Inc. 2
- Keeler Instruments, Inc. 2
- Artiberia 2
- Cilco, Inc. 1
- Mentor O & O, Inc. 1
- American Pharmaseal Div. Ahsc 1
- Downs Surgical , Ltd. 1
- Ascon Medical Instruments, Ltd. 1
- Mira, Inc. 1
- Precision-Cosmet Co., Inc. 1
- CooperVision, Inc. 1
- Medical Technology Development Corp. 1
- Jedmed Instrument Co. 1
- Allergan, Inc. 1
- Staar Surgical Co. 1
- Stephens Instruments 1
- Concept, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022835 | Stephens Disposable ForcepsHNR · Traditional | Stephens Instruments | 11/01/2002SE |
| K895434 | Alcon Folding ForcepsHNR · Traditional | Alcon Laboratories | 12/04/1989SE |
| K891487 | Soft Lens Folding BlockHNR · Traditional | Western Medical Products, Inc. | 08/15/1989SE |
| K893199 | Phaco-Injector(Tm) Intraocular Lens Implant InstrHNR · Traditional | Allergan Medical Optics | 06/16/1989SE |
| K885230 | Mcdonald Folding ForcepsHNR · Traditional | Alcon Laboratories | 05/17/1989SE |
| K881049 | Bradbury Intraocular Retinal Kit Cat #200HNR · Traditional | Microline Pentax, Inc. | 09/12/1988SE |
| K883197 | Iol Implantation ForcepsHNR · Traditional | D & D Surgical | 08/22/1988SE |
| K880274 | Advanced Surgical Products Scleral Plug ForcepsHNR · Traditional | Advanced Surgical Products, Inc. | 02/05/1988SE |
| K864266 | Ophthalmic Knife & ForcepsHNR · Traditional | Western Medical Products, Inc. | 11/28/1986SE |
| K864183 | Ophthalmic Surgical InstrumentsHNR · Traditional | Techno Ophthalmics Intl. | 11/28/1986SE |
| K864071 | Faulkner ForcepsHNR · Traditional | Staar Surgical Co. | 11/13/1986SE |
| K864003 | Paco-Folder (TM) Intraocular Lens ForcepsHNR · Traditional | Allergan, Inc. | 10/31/1986SE |
| K863992 | Thornton Titanium Forceps (Various Types)HNR · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863991 | Thorton Titanium Needleholders(No,W Catch & StandHNR · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863727 | Fixation InstrumentsHNR · Traditional | Medical Technology Development Corp. | 10/31/1986SE |
| K861141 | Manual Ophthalmic Surgical InstrumentsHNR · Traditional | CooperVision, Inc. | 04/24/1986SE |
| K861057 | Manual Ophthalmic Surgical InstrumentsHNR · Traditional | Precision-Cosmet Co., Inc. | 04/24/1986SE |
| K860915 | Storz/Mazzacco Lens ForcepHNR · Traditional | Storz Instrument Co. | 04/15/1986SE |
| K854869 | Intraocular Forceps & ScissorsHNR · Traditional | Mira, Inc. | 03/05/1986SE |
| K852057 | Ascon Surgical InstrumentsHNR · Traditional | Ascon Medical Instruments, Ltd. | 06/27/1985SE |
| K851792 | 37-940 to 37-944 Various Noyes Ophthalmic ForcepsHNR · Traditional | Artiberia | 05/30/1985SE |
| K851791 | 37-610 to 37-880 Various Ophthal-ForcepsHNR · Traditional | Artiberia | 05/30/1985SE |
| K850119 | Pharmaseal Eye Prep TrayHNR · Traditional | American Pharmaseal Div. Ahsc | 05/09/1985SE |
| K844129 | Shure Grip Tying ForcepsHNR · Traditional | Mentor O & O, Inc. | 11/21/1984SE |
| K843992 | Cilcor Ophthalmic InstrumentsHNR · Traditional | Cilco, Inc. | 11/21/1984SE |
| K842697 | Rootman Orbital Surgery Instrument SetHNR · Traditional | Downs Surgical , Ltd. | 08/07/1984SE |
| K834355 | Micro ForcepsHNR · Traditional | Jedmed Instrument Co. | 03/16/1984SE |
| K823174 | Microsurgical InstrumentsHNR · Traditional | Concept, Inc. | 11/16/1982SE |
| K811658 | Anis Lens Implant Forceps #2HNR · Traditional | American V. Mueller | 06/26/1981SE |
| K803194 | Fisher-Pickering Intraocular Eye MagnetHNR · Traditional | Storz Instrument Co. | 02/04/1981SE |
| K801467 | Dodick Lens Holding ForcepsHNR · Traditional | Edward Weck, Inc. | 07/28/1980SE |
| K801465 | Gaskin Fragment Forceps(Mfg. Non-SterileHNR · Traditional | Edward Weck, Inc. | 07/28/1980SE |
| K800368 | Ophthalmic ForcepsHNR · Traditional | Edward Weck, Inc. | 03/12/1980SE |
| K791986 | Fix. & Lens For. #'S 3510,3512,3248,3795HNR · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K771003 | Lieberman Polack Double Corneal ForcepsHNR · Traditional | Edward Weck, Inc. | 06/17/1977SE |
| K770105 | Shepard II, Lens Forcep W/ LockHNR · Traditional | Edward Weck, Inc. | 01/25/1977SE |
| K770101 | Shepard Lens Forcep W/ Irrigator & LockHNR · Traditional | Edward Weck, Inc. | 01/25/1977SE |
| K770104 | Binkhorst Lens Forceps W/Out IrrigatorHNR · Traditional | Edward Weck, Inc. | 01/24/1977SE |
| K770102 | Hershman Lens Forceps W/Out IrrigatorHNR · Traditional | Edward Weck, Inc. | 01/24/1977SE |
| K770100 | Binkhorst Lens Forcep W/ IrrigatorHNR · Traditional | Edward Weck, Inc. | 01/24/1977SE |
| K770099 | Shepard Lens Forcep W/ Irriga W/Out LockHNR · Traditional | Edward Weck, Inc. | 01/24/1977SE |
| K770097 | Hershman Lens Forceps with IrrigatorHNR · Traditional | Edward Weck, Inc. | 01/24/1977SE |
| K761252 | Weck Tying Forcep, Curved TitaniumHNR · Traditional | Edward Weck, Inc. | 12/16/1976SE |
| K761251 | Weck Tying Forcep, Straight TitaniumHNR · Traditional | Edward Weck, Inc. | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2080-2026 Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number:…Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for… | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2079-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2078-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2077-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2076-2026 Class II | DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2075-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2074-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2073-2026 Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2072-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2071-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2070-2026 Class II | DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-2069-2026 Class II | DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number:…Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Katalyst Surgical, LLC | 03/25/2026Open, Classified |
| Z-1247-2026 Class II | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | Vortex Surgical Inc. | 12/16/2025Open, Classified |
| Z-0970-2024 Class II | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea.… | Vortex Surgical Inc. | 12/18/2023Terminated |
| Z-2433-2008 | BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref:…Metal particulates present. | Becton Dickinson and Company | 07/07/2008Terminated |
| Z-1461-2008 | Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical…Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction. | Alcon Research, Ltd | 03/07/2008Terminated |