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Refractor, Manual, Non-Powered, Including Phoropter
FDA product code HKN · Class 1 · Ophthalmic
70
Registered devices
39
Adverse events
7
Recalls
3
510(k) clearances
Devices with this code
Lombart — INNOVA Medical Ophthalmics IncIBEX Manual Refractor — Trevi Technology, Inc.MEASURING HEAD CONNECTION CABLE(14m) for COMPU VISION CV-5000 — TOPCON CORPORATIONTAKAGI — TAKAGI SEIKO CO.,LTD.INFRARED COMMUNICATION UNIT — TOPCON CORPORATIONVISION TESTER — Chongqing Yeasn Science & Technology Co.,Ltd.COMPU VISION CV-5000 — TOPCON CORPORATIONS4 Optik — Lombart Brothers, Inc.Rexxam — REXXAM CO., LTD.Illuminated Phoropter — REICHERT, INC.Vision-R 800 — ESSILOR INTERNATIONALFully Assisted Refraction System — NIDEK CO.,LTD.Vision-S 700 — ESSILOR INTERNATIONALILLUMINIX — Illuminix Industries LLCVision-R 800 — ESSILOR INTERNATIONAL3nethra — FORUS HEALTH PRIVATE LIMITEDMedizs Digitalized Refractor DR-19 — MEDIZS Inc.SightChek Digital Phoropter — REICHERT, INC.LuxVsion — U.S. OPHTHALMIC, L.L.C.Vision-R 700 — ESSILOR INTERNATIONALGilras — U.S. OPHTHALMIC, L.L.C.Tabletop Refraction System — NIDEK CO.,LTD.MOPTIM — Shenzhen CERTAINN Technology Co., Ltd.Vision-R 700 — ESSILOR INTERNATIONAL
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-28 | Reichert, Inc. | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. |
| 2025-02-28 | Reichert, Inc. | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. |
| 2023-07-20 | Reichert, Inc. | 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, |
| 2018-06-14 | Nidek Inc. | The lens bonding was incomplete on the refractor. |
| 2017-12-06 | Reliance Medical Products Inc | 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 o |
| 2016-02-29 | Nidek Inc | 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 inju |
| 2014-06-09 | Nidek Inc | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. |
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