Pump, Infusion, Ophthalmic
General Hospital · 21 CFR 880.5725
Recent MDR events
134 adverse event reports on file
- Streamline Surgical SystemJul 27, 2026InjuryNew World Medical, Inc.1000125279-2026-00031
- OMNI EDGE SURGICAL SYSTEMJul 22, 2026InjurySight Sciences Inc3010363671-2026-00010
- OMNI EDGE SURGICAL SYSTEMJul 14, 2026InjurySight Sciences Inc3010363671-2026-00009
- OMNI EDGE SURGICAL SYSTEMJun 18, 2026InjurySight Sciences Inc3010363671-2026-00008
- OMNI EDGE SURGICAL SYSTEMMay 11, 2026InjurySight Sciences Inc3010363671-2026-00006
- OMNI SURGICAL SYSTEMMay 3, 2026InjurySight Sciences Inc3010363671-2026-00004
- OMNI SURGICAL SYSTEMMay 1, 2026InjurySight Sciences Inc.,3010363671-2026-00003
- STREAMLINE SURGICAL SYSTEMApr 23, 2026InjuryNew World Medical, Inc.1000125279-2026-00015
- STREAMLINE SURGICAL SYSTEMMar 30, 2026InjuryNew World Medical, Inc.1000125279-2026-00014
- OMNI EDGE SURGICAL SYSTEMMar 24, 2026InjurySight Sciences Inc3010363671-2026-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
31 firms currently registered for this product code
Sterigenics U.s. Llc
Hayward, CA, US
Microsurgical Technology, Inc.
Redmond, WA, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Isomedix Operations, Inc.
Minneapolis, MN, US
Sight Sciences, Inc.
Menlo Park, CA, US
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Nova Eye Inc.
Fremont, CA, US
Peter's Technology (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Bausch & Lomb Incorporated
Rochester, NY, US
New World Medical, Inc.
Rancho Cucamonga, CA, US
Steris Tomoe (thailand) Ltd.
Chonburi Chon Buri, TH
Pt Medtech Th Co., Ltd
PHRA NAKHON SI AYUTTHAYA, TH
Isomedix Operations Inc.
S Plainfield, NJ, US
Sterigenics U.s., Llc
Corona, CA, US
Isomedix Operations, Inc.
Libertyville, IL, US
510(k) clearances
20 clearances for this product code
- Sight Sciences, Inc.Aug 4, 2026
K253760 · OMNI Ultra Surgical System (1-110)
- New World Medical, Inc.Feb 14, 2025
K243503 · VIA360 Surgical System
- Sight Sciences, Inc.Aug 25, 2023
K232214 · OMNI Surgical System
- Microsurgical Technologies, Inc.Jun 8, 2022
K213173 · TrabEx Pro
- GlaukosJan 6, 2022
K212797 · iPrime Viscodelivery System
- New World Medical, Inc.Oct 8, 2021
K211680 · Streamline Surgical System
- Sight Sciences, Inc.Mar 1, 2021
K202678 · OMNI Surgical System
- Sight Sciences, Inc.Aug 11, 2020
K201953 · OMNI PLUS Surgical System