Instrument, Measuring, Corneal Radius
Ophthalmic · 21 CFR 886.1450
Recent MDR events
22 adverse event reports on file
- AL-SCANJul 26, 2016MalfunctionNidek Co., Ltd.3002807715-2016-00029
- AL-SCANJul 26, 2016InjuryNidek Co., Ltd.3002807715-2016-00030
- AL-SCANJul 26, 2016InjuryNidek Co., Ltd.3002807715-2016-00031
- AL-SCANJun 27, 2016InjuryNidek Co., Ltd3002807715-2016-00022
- AL-SCANJun 27, 2016InjuryNidek Co., Ltd.3002807715-2016-00024
- AL-SCANJun 27, 2016InjuryNidek Co., Ltd3002807715-2016-00025
- VERION REFERENCE UNITJun 26, 2015InjuryWavelight Gmbh (agps)3010300699-2015-00504
- VERION REFERENCE UNITJun 26, 2015InjuryWavelight Gmbh (agps)3010300699-2015-00505
- VERION REFERENCE UNITJun 26, 2015InjuryWavelight Gmbh (agps)3010300699-2015-00506
- REFERENCE UNITMar 13, 2015InjuryWavelight Gmbh Agps3010300699-2015-00001
Event type breakdown
Recalls
2 recall events for this product code
- Haag-Streit USA IncTerminatedJan 11, 2012
Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 King
Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.
Z-0638-2012 · View FDA record ↗ - Haag-Streit USA IncTerminatedAug 9, 2011
Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System.
A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
Z-2964-2011 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Huaian Frimen Co., Ltd
Huaian Jiangsu, CN
Teleflex Medical Llc
Morrisville, NC, US
Paul Instruments (india)
CALCUTTA West Bengal, IN
Med Saver, Inc.
PHOENIXVILLE, PA, US
Daud Jee Mfg Co
Sialkot Punjab, PK
Fischer Surgical Inc.
Imperial, MO, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Beijing Hongdee Corporation
Beijing, CN
Indo-german Surgical Corporation
Mumbai Maharashtra, IN
Wexler Surgical, Inc.
HOUSTON, TX, US
Pms Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Topcon Yamagata Co., Ltd
Yamagata-KEN, JP
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Teleflex Llc (nadc)
Olive Branch, MS, US
Stephens Instruments, Inc
LEXINGTON, KY, US
B&h Surgical Instrument
Sialkot Punjab, PK
Topcon Corp.
TOKYO, JP
510(k) clearances
5 clearances for this product code
- Marco Ophthalmic, Inc.Aug 9, 1993
K930444 · MARCO STANDARD KERATOMETERS
- R.H. Burton Co.Apr 5, 1993
K924779 · BURTON KERATOMETER - MODLE 2040
- Heidelberg InstrumentsDec 15, 1986
K864369 · LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
- Kera Corp.Nov 13, 1986
K864037 · KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
- Acufex Microsurgical, Inc.Sep 11, 1985
K852424 · ACUFEX COMPARATIVE SURGICAL KERATOMETER