Topographer, Corneal, Ac-powered
Ophthalmic · 21 CFR 886.1350
Recent MDR events
9 adverse event reports on file
- ZEISS ATLAS TOPOGRAPHERFeb 13, 2025MalfunctionCarl Zeiss Meditec Ag (jena)MW5166121
- ALLEGRO TOPOLYZER VARIOSep 28, 2020MalfunctionWavelight Gmbh3003288808-2020-00579
- ALLEGRO TOPOLYZER VARIODec 2, 2019MalfunctionWavelight Gmbh3003288808-2019-01178
- ALLEGRO TOPOLYZER VARIOJul 10, 2019MalfunctionWavelight Gmbh3003288808-2019-00708
- ALLEGRO TOPOLYZER VARIOOct 24, 2017InjuryWavelight Gmbh3003288808-2017-02289
- ALLEGRO TOPOLYZER VARIOSep 12, 2017MalfunctionWavelight Gmbh3003288808-2017-02013
- ALLEGRO TOPOLYZER VARIOAug 23, 2017MalfunctionWavelight Gmbh3003288808-2017-01948
- CASSINIDec 1, 2014MalfunctionI-optics Bv3008251789-2014-00001
- ALLEGRO TOPOLYZER VARIONov 30, 2012MalfunctionWavelight Gmbh3003288808-2012-00494
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
36 firms currently registered for this product code
Oculus, Inc.
Arlington, WA, US
Shenzhen Certainn Technology Co., Ltd.
Shenzhen Guangdong, CN
Shanghai Mediworks Precision Instruments Co., Ltd.
Shanghai, CN
Hedgefog Research Inc.
San Pedro, CA, US
Precision Technology Services Ltd
Cambridge Ontario, CA
Huvitz Co., Ltd.
Anyang-si Gyeonggi, KR
Medmont International Pty Ltd
Nunawading Victoria, AU
Sbm Sistemi Srl
Rivalta di Torino, IT
Eyevis Mediworks Private Limited
Ahmedabad Gujarat, IN
Keeler Ltd.
WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
Advanced Ophthalmic Systems Ltd
Weybridge, Surrey, GB
Ningbo Flo Optical Technology Development Co., Ltd.
Ningbo Zhejiang, CN
Chongqing Sunkingdom Medical Instrument Co.,ltd
Chongqing, CN
Reichert Inc.
DEPEW, NY, US
Adom Advanced Optical Technologies Ltd.
Lod Central, IL
Oculus Optikgerate Gmbh
WETZLAR Hesse, DE
Cassini Technologies B.v.
The Hague Zuid-Holland, NL
Optovue, Inc.
San Jose, CA, US
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Euclid Vision Corporation
Sterling, VA, US
Ai4eyes Medical Technologies, Inc.
Saint-Laurent Quebec, CA
Innova Medical Ophthalmics
Toronto Ontario, CA
Carl Zeiss Meditec Ag (jena)
Jena Thuringia, DE
Apramed Industria E Comercio De Aparelhos Medicos Ltda
SAO CARLOS Sao Paulo, BR
Accutome, Inc.
Malvern, PA, US
510(k) clearances
5 clearances for this product code
- Bio-Medical Sciences, Inc.Dec 7, 1998
K981665 · SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
- Euclid Systems Corp.May 20, 1997
K964702 · EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
- Orbtek, Inc.Mar 26, 1997
K964891 · ORBSHOT KERATOMETER
- Eclipse VenturesDec 23, 1996
K963762 · CORNEAL TOPOGRAPHER 200
- Par Vision Systems Corp.Jun 14, 1995
K950077 · INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)