Sponge, Ophthalmic
Ophthalmic · 21 CFR 886.4790
Recent MDR events
62 adverse event reports on file
- ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACTNov 28, 2025InjuryBeaver-visitec International, Inc.1211998-2025-00016
- ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACTNov 28, 2025InjuryBeaver-visitec International, Inc.1211998-2025-00015
- ASHEVILLE EYE ASSOCIATES 2.4 BACK TABLE CATARACTNov 28, 2025InjuryBeaver-visitec International, Inc.1211998-2025-00017
- OCUSOFT LID SCRUB ALLERGYOct 2, 2024MalfunctionOcusoft, Inc.MW5160516
- OCUSOFTSep 9, 2024InjuryUnkMW5159451
- SURG EYE SPEARS-10/PK-10PK/CS, SURG EYE SPEARS-10/PK-10PK/CSAug 9, 2024InjuryDeroyal Intercontinental, S.r.l3004605321-2023-00006
- OCUSOFT LID SCRUB PLUSAug 11, 2023InjuryUnknownMW5123244
- OCUSOFT LID SCRUB PLUSAug 11, 2023InjuryUnknownMW5123251
- BEAVER-VISITECJul 20, 2023MalfunctionBeaver-visitec International Inc3014527682-2023-00008
- OCUSOFTApr 27, 2023InjuryGo Pro Now, Ltd.MW5117118
Event type breakdown
Recalls
10 recall events for this product code
- Carwild CorporationOpen, ClassifiedJan 2, 2025
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Z-0798-2025 · View FDA record ↗ - Carwild CorporationOpen, ClassifiedJan 2, 2025
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Z-0799-2025 · View FDA record ↗ - Carwild CorporationOpen, ClassifiedJan 2, 2025
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Managem
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Z-0800-2025 · View FDA record ↗ - Beaver Visitec International, Inc.Open, ClassifiedMar 1, 2023
Ultracell Wick with 80cc Collection Bag, 20/box
Device packaging may contain open seals, compromising product sterility.
Z-1199-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0481-2023 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile
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-1593-2022 · View FDA record ↗ - DeRoyal Industries IncTerminatedNov 14, 2013
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Z-0275-2014 · View FDA record ↗ - Ultracell Medical TechnologiesTerminatedJan 30, 2003
Ultrakleen KSponge II Spears
Sterility of the device is compromised
Z-0487-03 · View FDA record ↗ - Ultracell Medical TechnologiesTerminatedJan 30, 2003
PVA Foam Surgical Spears
Sterility of the device is compromised
Z-0488-03 · View FDA record ↗ - Ultracell Medical TechnologiesTerminatedJan 30, 2003
Lasik Spears Blunt (5)
Sterility of the device is compromised
Z-0489-03 · View FDA record ↗
Registered firms
118 firms currently registered for this product code
Bioseal
PLACENTIA, CA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Carwild Corp.
NEW LONDON, CT, US
L&r Usa Inc.
Milwaukee, WI, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cenefom Corp
Zhunan Township Miaoli, TW
Questalpha Gmbh & Co. Kg
Eschenburg Hesse, DE
Millennium Surgical Corp
Schaumburg, IL, US
Sterigenics U.s., Llc
Corona, CA, US
Professional Contract Sterilization, Inc.
Taunton, MA, US
Microspecialties Llc
Middletown, CT, US
Gri Medical & Electronic Technology Co., Ltd.
JIAXING Zhejiang, CN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Shenzhen Jpy Ion-tech. Co., Ltd.
Shenzhen Guangdong, CN
Katena Products, Inc.
Parsippany, NJ, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Invotec International, Inc.
Jacksonville, FL, US
Isomedix Operations Inc.
CHESTER, NY, US
Rumex Baltics Sia
Riga, LV
Rumex International Co.
Tampa, FL, US
Swann-morton(services) Limited
Owlerton Green Sheffield, GB
Ready Set Import
Beverly Hills, CA, US
510(k) clearances
47 clearances for this product code
- Huizhou Foryou Medical Devices Co., Ltd.Oct 30, 2013
K132796 · SUNTOUCH EYE SPEAR
- Network Medical Products, Ltd.Oct 29, 2013
K130117 · NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
- Alphamed, Inc.Oct 23, 2009
K091240 · ALPHAMED SURGICAL SPEAR, MODEL 70-5000
- Longtek Scientific Co., Ltd.Dec 15, 2008
K082460 · CENEFOM PVA SURGICAL SPEAR
- Ultracell Medical Technologies, Inc.Aug 24, 2001
K012196 · ULTRACELL ABSORBENT STICK
- Medtronic Xomed, Inc.Jun 26, 2001
K011191 · MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
- Prescott'S, Inc.Apr 13, 2001
K003842 · PRESCOTT'S SURGICAL SPEAR
- Med-Logics, Inc.Aug 18, 2000
K002279 · ML EYE SPEAR, MODEL ML 27 ES