Home › Device types › HOZ
Sponge, Ophthalmic
FDA product code HOZ · Class 2 · Ophthalmic
441
Registered devices
62
Adverse events
10
Recalls
47
510(k) clearances
Devices with this code
Janach — NETWORK MEDICAL PRODUCTS LIMITEDWalcott — Summit Medical, Inc.Eyetec — NETWORK MEDICAL PRODUCTS LIMITEDUltracell — Beaver-Visitec International, Inc.Keracel — Beaver-Visitec International, Inc.Merocel — Beaver-Visitec International, Inc.PRO-PAKS®️ — MICROSPECIALITIES, INC.Dukal — Dukal LLCOphthalmic Pledget — AMERICAN SURGICAL COMPANY, LLCWalcott — Summit Medical, Inc.Atlanta Healthcare Services OcuDrape® — ATLANTA HEALTHCARE SERVICES, INC.PRO-PAKS®️ — MICROSPECIALITIES, INC.MSI — Beaver-Visitec International, Inc.Eyetec — NETWORK MEDICAL PRODUCTS LIMITEDMSI Precision Specialty Instruments — Med Saver, Inc.Eyetec — NETWORK MEDICAL PRODUCTS LIMITEDUltracell® — Beaver-Visitec International, Inc.Eyetec — NETWORK MEDICAL PRODUCTS LIMITEDUltracell — Beaver-Visitec International, Inc.Eyetec — NETWORK MEDICAL PRODUCTS LIMITEDEyetec — NETWORK MEDICAL PRODUCTS LIMITEDPro-Paks — MICROSPECIALITIES, INC.WALCOTT RX PRODUCTS — Summit Medical, Inc.Kitpack — NETWORK MEDICAL PRODUCTS LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2022-12-20 | Beaver Visitec International, Inc. | Device packaging may contain open seals, compromising product sterility. |
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may r |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2013-08-12 | DeRoyal Industries Inc | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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