Refractometer, Ophthalmic
Ophthalmic · 21 CFR 886.1760
Recent MDR events
174 adverse event reports on file
- VS100 Spot Vision ScreenerJul 27, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00322
- VS100 Spot Vision ScreenerJul 27, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00324
- VS100 SPOT VISION SCREENERJul 16, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00319
- VS100 SPOT VISION SCREENERJul 8, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00316
- VS100 SPOT VISION SCREENERJul 7, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00313
- VS100 SPOT VISION SCREENERMay 29, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00307
- VS100 SPOT VISION SCREENERMay 29, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00306
- VS100 SPOT VISION SCREENERMay 29, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00308
- VS100 SPOT VISION SCREENERMay 27, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00305
- VS100 SPOT VISION SCREENERMay 26, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00304
Event type breakdown
Recalls
5 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedMar 18, 2026
Brand Name: Welch Allyn, Inc.
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Z-1573-2026 · View FDA record ↗ - Nidek IncTerminatedAug 27, 2015
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic
Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
Z-2477-2015 · View FDA record ↗ - Canon Inc.TerminatedMay 25, 2013
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA.
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
Z-1404-2013 · View FDA record ↗ - Carl Zeiss Meditec AGTerminatedUnknown
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric cha
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
Z-0614-2021 · View FDA record ↗ - Nidek Inc.TerminatedUnknown
AUTO REF/KERATOMETER ARK-1s
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Z-1348-2018 · View FDA record ↗
Registered firms
75 firms currently registered for this product code
Adaptica Srl
Padova, IT
Appasamy Associates Private Limited ( Thirubhuvanai))
Mannadipet Commune Puducherry, IN
Taiyuan North China Xinyuan Tech. Center (co., Ltd.)
TAIYUAN Shaanxi, CN
Apramed Industria E Comercio De Aparelhos Medicos Ltda
SAO CARLOS Sao Paulo, BR
Luneau Technology Operations
Pont-de-l'Arche Eure, FR
Canon.inc
OHTA-KU Tokyo, JP
Rexxam.co., Ltd.
Takamatsu Kagawa, JP
Ningbo Ming Sing Optical R&d Co., Ltd.
Ningbo Zhejiang, CN
Toyo Medical Co.
Doral, FL, US
Beijing Home Vision Ai Tech Co.,ltd.
Beijing, CN
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Potec Co., Ltd.
DAEJEON, KR
Aspen Surgical Products, Inc.
Caledonia, MI, US
Chongqing Sunkingdom Medical Instrument Co.,ltd
Chongqing, CN
Pursuant Health
Alpharetta, GA, US
Remidio Innovative Solutions Inc
Glen Allen, VA, US
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Wuxi Zontai Int'l Corporation Ltd.
WUXI Jiangsu, CN
Shanghai Link Instruments Co.,ltd
Changzhou City Jiangsu, CN
Ningbo Flo Optical Technology Development Co., Ltd.
Ningbo Zhejiang, CN
Aurolab
MADURAI Tamil Nadu, IN
Shanghai Mediworks Precision Instruments Co., Ltd.
Shanghai, CN
Stereo Optical Company Llc
CHICAGO, IL, US
Lianyungang Tiannuo Optical Instrument Co., Ltd.
LIANYUNGANG Jiangsu, CN
Eyeque Corporation
Newark, CA, US
510(k) clearances
35 clearances for this product code
- Topcon Medical Systems, Inc.Dec 19, 2003
K031831 · TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
- Visx, IncorporatedMay 2, 2000
K000327 · WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
- Kudi Kalu, Inc.May 30, 1995
K951179 · DIGITAL RETINOSCOPIC PHOTOMETER
- Tomey Corporation USAMar 1, 1995
K945959 · VIDEO VISION ANALYZER (VIVA), VRB 100
- Cannon U.S.A., Inc.Sep 2, 1994
K942242 · AUTO REF-KERATOMETER, RK-3
- Canon, Inc.Jul 12, 1994
K940516 · AUTO REFF-30
- Canon USA, Inc.Feb 17, 1994
K925304 · AUTOREF LENSMETER RL-10
- Stereo Optical Co., Inc.Apr 6, 1993
K924741 · OPTEC 3000