Apparatus, Cautery, Radiofrequency, Ac-powered
Ophthalmic · 21 CFR 886.4100
Recent MDR events
32 adverse event reports on file
- SYNERGETICSOct 11, 2024MalfunctionSynergetics, Inc.20425768
- INTREPID AUTOSERT IOL HANDPIECEJul 24, 2024InjuryAlcon Research, Llc - Irvine Technology Center2028159-2024-01083
- ENDO-DIATHERMY HANDLE, STRAIGHT POINTED TIP.(25 GAUGE / 0.5 MM)Jul 1, 2024MalfunctionD.o.r.c. Dutch Ophthalmic Research Center Int.1222074-2024-00021
- INTREPID AUTOSERT IOL HANDPIECEJan 3, 2022InjuryAlcon Research, Llc - Irvine Technology Center2028159-2022-00002
- INTREPID AUTOSERT IOL HANDPIECEOct 5, 2021InjuryAlcon Research, Llc - Irvine Technology Center2028159-2021-01148
- MST TRABECTOMEAug 13, 2021Malfunction3019924-2021-00002
- INTREPID AUTOSERT IOL HANDPIECEFeb 25, 2020InjuryAlcon Research, Llc - Irvine Technology Center2028159-2020-00144
- ULTRAFLOW BIMANUAL I/A HANDPIECE SET DSPJul 22, 2018InjuryAlcon Grieshaber Ag3003398873-2018-00014
- BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MMMay 21, 2018MalfunctionDutch Opthalmic Research Center Bv1222074-2018-00141
- INTREPID AUTOSERT IOL HANDPIECEMar 30, 2018InjuryAlcon Research, Ltd. - Irvine Technology Center2028159-2018-00654
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
35 firms currently registered for this product code
Alcon Grieshaber Ag
Neuhausen Schaffhausen, CH
Biomerics
Salt Lake City, UT, US
Sterigenics Eo Canada, Inc.
Mississauga Ontario, CA
Synergetics, Inc.
O Fallon, MO, US
Alcon Grieshaber Ag
SCHAFFHAUSEN, CH
Rm Healthcare Products Sa De Cv
JUAREZ Chihuahua, MX
Isomedix Operations Inc.
CHESTER, NY, US
Lake Region Medical
CHASKA, MN, US
Sterigenics U.s., Llc
Corona, CA, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Microsurgical Technology, Inc.
Redmond, WA, US
Walsh Medical Devices, Inc.
OAKVILLE Ontario, CA
Alcon Research, Llc
Sinking Spring, PA, US
Isomedix Operations, Inc.
Libertyville, IL, US
Alcon Laboratories Belgium
Puurs-Sint-Amands Antwerpen, BE
Harmac Medical Products, Inc./h3 De Tijuana, S. De Rl De C.v.
Tijuana Baja California, MX
Alcon Research, Llc
Houston, TX, US
Alcon Research, Llc
IRVINE, CA, US
Midwest Sterilization Corp.
JACKSON, MO, US
Sterigenics U.s., Llc
Queensbury, NY, US
Alcon Research, Llc
Lake Forest, CA, US
Sterigenics Us Llc
Fort Worth, TX, US
510(k) clearances
11 clearances for this product code
- Starion InstrumentsFeb 25, 2005
K050308 · THERMAL CAUTERY PROBE
- Ophthalmic Technologies, Inc.Apr 4, 1999
K990064 · DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
- Refractec, Inc.Jul 22, 1998
K980522 · REFRACTEC MCS-100
- C.M. Chance , Ltd.Mar 13, 1998
K972749 · PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
- StorzMar 4, 1996
K952151 · STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
- Ellman Intl., Inc.Feb 9, 1996
K955158 · SURGITRON
- Gamp & Assoc.Jan 5, 1996
K952569 · GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
- Mira, Inc.Jul 15, 1994
K941495 · RETURN PATH DIATHERMY HANDLE