Sponge, Ophthalmic
FDA product code HOZ · Class II (moderate risk) · 21 CFR 886.4790 · Ophthalmic
47510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Visitec Co. 5
- Ultracell Medical Technologies, Inc. 4
- Jedmed Instrument Co. 3
- Ophthalmic Resources, Inc. 1
- Huizhou Foryou Medical Devices Co., Ltd. 1
- Katena Products, Inc. 1
- Sparta Surgical Corp. 1
- Alcon Laboratories 1
- Solos Ophthalmology 1
- Ascon Medical Instruments, Ltd. 1
- Marwood Medical, Inc. 1
- Associated Medical Products Co. 1
- Winn Hirsch & Assoc. 1
- Biological & Environmental Control Laboratories 1
- Professional Medical Services 1
- Storz Instrument Co. 1
- Surgicot, Inc. 1
- Ritmed, Inc. 1
- Secol Co. 1
- Medical Instrument Research Assoc., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132796 | Suntouch Eye SpearHOZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 10/30/2013SE |
| K130117 | Network Eye Spears, Points, Drains, Wicks and ShieldsHOZ · Traditional | Network Medical Products, Ltd. | 10/29/2013SE |
| K091240 | Alphamed Surgical Spear, Model 70-5000HOZ · Traditional | Alphamed, Inc. | 10/23/2009SE |
| K082460 | Cenefom Pva Surgical SpearHOZ · Traditional | Longtek Scientific Co., Ltd. | 12/15/2008SE |
| K012196 | Ultracell Absorbent StickHOZ · Traditional | Ultracell Medical Technologies, Inc. | 08/24/2001SE |
| K011191 | Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic SpongesHOZ · Traditional | Medtronic Xomed, Inc. | 06/26/2001SE |
| K003842 | Prescott's Surgical SpearHOZ · Traditional | Prescott'S, Inc. | 04/13/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | Med-Logics, Inc. | 08/18/2000SE |
| K993883 | M-Pact Corneal Light ShieldHOZ · Traditional | M-Pact Corp. | 12/21/1999SE |
| K990671 | Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument WipeHOZ · Traditional | Hurricane Medical | 05/10/1999SE |
| K990749 | Sof-Suction Fluid Evacuation SystemHOZ · Traditional | X-Tech Medical, LLC | 04/02/1999SE |
| K982599 | The Fremstad RingHOZ · Traditional | Ophthalmic Solutions, LLC | 02/16/1999SE |
| K974313 | Hydrofera Surgical SpearHOZ · Traditional | Hydrofera, LLC | 03/02/1998SE |
| K972633 | Ultracell Suction SpongeHOZ · Traditional | Ultracell Medical Technologies, Inc. | 12/17/1997SE |
| K972693 | Deroyal Industries, Inc. Surgical Eye SpearHOZ · Traditional | Deroyal Industries, Inc. | 09/30/1997SE |
| K971832 | Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80CC, Ivalon Eye Drain, 400CC, Ivalon Eye…HOZ · Traditional | M-Pact Worldwide Management Corp. | 07/31/1997SE |
| K964855 | Expandacell Eye Spear, Eye Wick, Wick Drain and Corneal ShieldHOZ · Traditional | Shippert Medical Technologies Corp. | 03/04/1997SE |
| K946016 | Ivalon Ophthalmic SpongeHOZ · Traditional | Ivalon | 03/22/1995SE |
| K950241 | Ophthalmic SpongesHOZ · Traditional | Oasis Medical, Inc. | 02/27/1995SE |
| K942642 | Surgi-WipeHOZ · Traditional | Surgin Surgical Instrumentation, Inc. | 07/15/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | Visitec Co. | 12/27/1993SE |
| K923922 | Surgical SpearsHOZ · Traditional | Ultracell Medical Technologies, Inc. | 03/19/1993SE |
| K920354 | Ophthalmic SpongesHOZ · Traditional | Ultracell Medical Technologies, Inc. | 08/05/1992SE |
| K910707 | Operaid Surgical Drain W/ Corneal ShieldsHOZ · Traditional | Jedmed Instrument Co. | 04/10/1991SE |
| K902750 | Visi-Swab Ophtalmic SpongeHOZ · Traditional | Visitec Co. | 07/26/1990SE |
| K900786 | Visi-Sorb Absorbant StickHOZ · Traditional | Visitec Co. | 05/18/1990SE |
| K897034 | K-SpongeHOZ · Traditional | Katena Products, Inc. | 02/15/1990SE |
| K896705 | Visitec Micro-Sponge SpearsHOZ · Traditional | Visitec Co. | 01/11/1990SE |
| K896084 | MicrospearsHOZ · Traditional | Sparta Surgical Corp. | 11/02/1989SE |
| K896004 | Alcon Surgical SpongeHOZ · Traditional | Alcon Laboratories | 11/02/1989SE |
| K885232 | Fluid Drainage WickHOZ · Traditional | Visitec Co. | 02/08/1989SE |
| K872612 | Solos Eyesite SpongesHOZ · Traditional | Solos Ophthalmology | 07/31/1987SE |
| K852055 | Ascon Ophthalmic SpongeHOZ · Traditional | Ascon Medical Instruments, Ltd. | 09/04/1985SE |
| K850340 | Eye Procedure PackHOZ · Traditional | Marwood Medical, Inc. | 05/22/1985SE |
| K842983 | Ampco Opthalmic TrayHOZ · Traditional | Associated Medical Products Co. | 05/22/1985SE |
| K842601 | Pre-Operative Ophthalmic Dressing TrayHOZ · Traditional | Ophthalmic Resources, Inc. | 05/10/1985SE |
| K842990 | Sterile Eye Surgery KitsHOZ · Traditional | Biological & Environmental Control Laboratories | 05/09/1985SE |
| K850050 | PMS Ophthalmology Pack-Pms Eye Tray/PackHOZ · Traditional | Professional Medical Services | 04/23/1985SE |
| K850883 | Scleral Sponge II, Olk Design, E5395-10 & E5395-11HOZ · Traditional | Storz Instrument Co. | 03/20/1985SE |
| K841721 | Operaid Surgical DrainHOZ · Traditional | Jedmed Instrument Co. | 11/21/1984SE |
| K840471 | Eye SpearHOZ · Traditional | Surgicot, Inc. | 03/16/1984SE |
| K834356 | Eye Sponge or SpearHOZ · Traditional | Jedmed Instrument Co. | 03/16/1984SE |
| K830262 | Floret Ophthalmic Eye SpearHOZ · Traditional | Ritmed, Inc. | 04/06/1983SE |
| K802794 | Pro-Ophta SticksHOZ · Traditional | Secol Co. | 12/22/1980SE |
| K780987 | Soft Silicone Elastomer Sponge ExplantHOZ · Traditional | Medical Instrument Research Assoc., Inc. | 09/28/1978SE |
| K780257 | MicrospearsHOZ · Traditional | Sparta Instrument Corp. | 02/23/1978SE |
| K761155 | Cellulose Eye StickHOZ · Traditional | Winn Hirsch & Assoc. | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0800-2025 Class II | Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm-…Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the… | Carwild Corporation | 10/22/2024Open, Classified |
| Z-0799-2025 Class II | Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical…Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the… | Carwild Corporation | 10/22/2024Open, Classified |
| Z-0798-2025 Class II | Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from…Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the… | Carwild Corporation | 10/22/2024Open, Classified |
| Z-1199-2023 Class II | Ultracell Wick with 80cc Collection Bag, 20/boxDevice packaging may contain open seals, compromising product sterility. | Beaver Visitec International, Inc. | 12/20/2022Open, Classified |
| Z-0481-2023 Class II | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |
| Z-1593-2022 Class II | Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0275-2014 Class II | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal…One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. | DeRoyal Industries Inc | 08/12/2013Terminated |