Refractor, Manual, Non-powered, Including Phoropter
Ophthalmic · 21 CFR 886.1770
Recent MDR events
39 adverse event reports on file
- CV-5000Apr 8, 2022MalfunctionTopcon Corporation9614661-2022-00001
- RT-5100Nov 30, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00025
- 1.RT-5100Aug 31, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00021
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00013
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00014
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00015
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00016
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00017
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00018
- RT-5100Jul 14, 2017MalfunctionNidek Co., Ltd.0002936921-2017-00019
Event type breakdown
Recalls
7 recall events for this product code
- Reichert, Inc.Open, ClassifiedMar 31, 2025
Phoroptor VRx Digital Refraction System
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Z-1500-2025 · View FDA record ↗ - Reichert, Inc.Open, ClassifiedMar 31, 2025
Phoroptor VRx Digital Refraction System
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Z-1501-2025 · View FDA record ↗ - Reichert, Inc.Open, ClassifiedAug 31, 2023
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye.
Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
Z-2512-2023 · View FDA record ↗ - Nidek IncTerminatedMar 24, 2016
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:
There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
Z-1245-2016 · View FDA record ↗ - Nidek IncTerminatedJun 23, 2014
RT-5100 Refractor and RT-3100 Refractor;
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Z-1853-2014 · View FDA record ↗ - Nidek Inc.TerminatedUnknown
RT-5100 Refractor, a component of the Epic-5100 System.
The lens bonding was incomplete on the refractor.
Z-0655-2019 · View FDA record ↗ - Reliance Medical Products IncTerminatedUnknown
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)
Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing
Z-1318-2018 · View FDA record ↗
Registered firms
64 firms currently registered for this product code
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Topcon Healthcare Solutions Emea Oy
OULU Pohjois-Pohjanmaa, FI
Huvitz Co., Ltd.
Anyang-si Gyeonggi, KR
Shenzhen Certainn Technology Co., Ltd.
Shenzhen Guangdong, CN
Blue.s4
Belleville Ontario, CA
Shanghai Huvitz Co., Ltd.
Shanghai, CN
Essilor International Usine De La Compasserie
Ligny en Barrois Meuse, FR
Luneau Technology Operations
Pont-de-l'Arche Eure, FR
Ningbo Flo Optical Technology Development Co., Ltd.
Ningbo Zhejiang, CN
Eyeque Corporation
Newark, CA, US
7051395 Canada Inc Dba Hta Direct Sourcing
Champlain, NY, US
Unicos Co., Ltd.
daejeon, KR
Beijing Hongdee Corporation
Beijing, CN
Shanghai Canton Optics Equipment Co., Ltd.
Shanghai, CN
H. Ogino & Co., Ltd.
Yokohama Kanagawa, JP
Towa Medical Instruments Co.,ltd.
Nakano-shi Nagano, JP
Nidek Incorporated
The Colony, TX, US
Apramed Industria E Comercio De Aparelhos Medicos Ltda
SAO CARLOS Sao Paulo, BR
Potec Co., Ltd.
DAEJEON, KR
Topcon Corp.
TOKYO, JP
Haag-streit Ag
KOENIZ Bern, CH
Taizhou City K&w International Trade Co.,ltd.
Jiangyan Jiangsu, CN
Ningbo Ming Sing Optical R&d Co., Ltd.
Ningbo Zhejiang, CN
Shanghai Link Instruments Co.,ltd
Changzhou City Jiangsu, CN
Everview Corp
Geumcheon-gu Seoul, KR
510(k) clearances
3 clearances for this product code