Unit, Phacofragmentation

Product Code: HQC

Ophthalmic Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 886.4670


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as HQC

4292Unit, PhacofragmentationPhacofragmentation System.

Total Product Life Cycle (TPLC) Devices

4292Unit, PhacofragmentationPhacofragmentation System.

Pre-market Notifications for HQC

K222236MiCOR System Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology Inc.
K214028MICOR Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology Inc.
K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)
K212241QUATERA 700Carl Zeiss Meditec AG
K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack And Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc.
K200584XPORT 304 (miCOR) System Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology Inc
K200207XPORT S Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology Inc.
K193376Visalis V500, Visalis S500Carl Zeiss Meditec AG
K192418Phacoemulsification Needle (Tip) And Irrigation SleeveRaico LLC
K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot PedalJohnson & Johnson Surgical Vision, Inc.
K191650LEGION SystemAlcon Research, LLC
K191024XPORT Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology Inc.
K170052Stellaris Elite Vision Enhancement SystemBausch + Lomb
K162342Stellaris Elite Vision Enhancement SystemBausch + Lomb
K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.

Global Unique Device Identification Database

10380659982252Unit, phacofragmentation
10380658202016Unit, phacofragmentation
10380658201019Unit, phacofragmentation
00380658176013Unit, phacofragmentation
00380658173012Unit, phacofragmentation
10380658120013Unit, phacofragmentation
10380658080027Unit, phacofragmentation
10380658075504Unit, phacofragmentation
10380658070011Unit, phacofragmentation
00380658036027Unit, phacofragmentation
10380657900234Unit, phacofragmentation
10380657900227Unit, phacofragmentation
10380657900203Unit, phacofragmentation
10380657900197Unit, phacofragmentation
10380657529183Unit, phacofragmentation

Maude Adverse Events

CENTURION VISION SYSTEM, FOOTSWITCHALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-31
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-31
STELLARIS ELITE VISION ENHANCEMENT SYSTEMBAUSCH + LOMB2020-03-30
STELLARIS ELITE ADAPTIVE FLUIDICS MICS PREMIUM PACKBAUSCH + LOMB2020-03-30
PHACO SURE TOUCH HANDPIECED.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA2020-03-30
MADLAB IRIS RETRACTORBAUSCH + LOMB2020-03-27
CENTURION VISION SYSTEM, ACCESSORY, HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-27
WHITESTAR SIGNATURE PRO CONSOLEJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-27
CENTURION VISION SYSTEM, ACCESSORY, HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-27
CENTURION VISION SYSTEM, ACCESSORY, HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-27
CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-26
INFINITI VISION SYSTEM, ACCESSORY, ULTRASOUND HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-26
WHITESTAR SIGNATURE PRO CONSOLEJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-24
CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-24
PHACO TIPALCON RESEARCH, LLC - ALCON PRECISION DEVICE2020-03-24
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-23
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-22
CENTURION VISION SYSTEM, ACCESSORY, HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-22
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
INFINITI VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
INFINITI VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
INFINITI VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
LAUREATE WORLD PHACO SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-19
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-18
INFINITI VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-18
INFINITI VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-18
EVA TDC VITRECTOMY PACK VGPC INPUT 27GD.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA2020-03-18
2.5 MM TRIPLE STEP FLARED PHACO NEEDLE (DISPOSABLE)D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA2020-03-17
INFINITI VISION SYSTEM, HANDPIECE TIPALCON RESEARCH, LLC - ALCON PRECISION DEVICE2020-03-16
WHITESTAR SIGNATURE SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-16
COMPACT INTUITIV PACK DISPOSABLE TUBING SETJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-16
LAUREATE WORLD PHACO SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-14
STELLARIS MICRO INCISION VACUUM PACKBAUSCH + LOMB2020-03-13
25G BI-B COMBINED ELITE W WFBAUSCH + LOMB2020-03-12
25G BI-B COMBINED ELITE W WFBAUSCH + LOMB INC2020-03-11
CONSTELLATION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-11
SOLO IA TIP, STRAIGHT, .3MMJOHNSON & JOHNSON SURGICAL VISION, INC.2020-03-11
CENTURION VISION SYSTEM, FOOTSWITCHALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-11
CENTURION VISION SYSTEMALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-11
CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECEALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER2020-03-11

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