Biomicroscope, Slit-lamp, Ac-powered
Ophthalmic · 21 CFR 886.1850
Recent MDR events
215 adverse event reports on file
- SLIT LAMPJul 13, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01045
- ESSILOR SLIT LAMP 650 WITH ANTERIOR SEGMENT CAMERA & SOFTWAREJul 7, 2026MalfunctionEssilor International Usine De La CompasserieMW5190369
- IOLMASTER 700Mar 13, 2026InjuryCarl Zeiss Meditec Ag (jena)9615030-2026-00016
- IOLMASTER 700Jan 15, 2026InjuryCarl Zeiss Meditec Ag (jena)9615030-2026-00001
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00024
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00025
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00026
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00027
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00028
- IOLMASTER 700Dec 18, 2025InjuryCarl Zeiss Meditec Ag (jena)9615030-2025-00029
Event type breakdown
Recalls
8 recall events for this product code
- Carl Zeiss Meditec AGTerminatedDec 1, 2015
IOL Master 5.5: Software versions 7.5 and 7.7;
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Z-0357-2016 · View FDA record ↗ - Carl Zeiss Meditec AGTerminatedDec 1, 2015
IOL Master 500: Software versions 7.5 and 7.7;
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
Z-0358-2016 · View FDA record ↗ - Carl Zeiss Meditec, Inc.TerminatedNov 15, 2013
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered,
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Z-0333-2014 · View FDA record ↗ - Carl Zeiss Meditec, Inc.TerminatedNov 15, 2013
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Z-0334-2014 · View FDA record ↗ - Carl Zeiss Meditec AGTerminatedUnknown
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany,
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
Z-0108-2019 · View FDA record ↗ - Carl Zeiss Meditec AGTerminatedUnknown
IOLMaster 700
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Z-1133-2021 · View FDA record ↗ - Haag-Streit USA IncOpen, ClassifiedUnknown
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Z-1560-2021 · View FDA record ↗ - Nidek IncTerminatedUnknown
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Z-2587-2016 · View FDA record ↗
Registered firms
118 firms currently registered for this product code
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Reichert Inc.
DEPEW, NY, US
Accutome, Inc.
Malvern, PA, US
Pacific Ophthalmic Supply
BELMONT, CA, US
Topcon Corp.
TOKYO, JP
Takagi Seiko Co., Ltd.
NAKANO-SHI Nagano, JP
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
S4optik Llc
Jacksonville, FL, US
66 Vision Tech Co., Ltd.
Suzhou Jiangsu, CN
Huvitz Co., Ltd.
Anyang-si Gyeonggi, KR
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Topcon Yamagata Co., Ltd
Yamagata-KEN, JP
Toyo Medical Co.
Doral, FL, US
Oculus Florida Service Center
Port Saint Lucie, FL, US
Medimaging Integrated Solution Inc.
Hsinchu Hsinchu (City), TW
Luneau Technology Operations
Pont-de-l'Arche Eure, FR
Keeler Ltd.
WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
Kowa Co. Ltd. Chofu
Chofu Tokyo, JP
510(k) clearances
108 clearances for this product code
- Carl Zeiss Vision GmbHMar 18, 2026
K253834 · VISUREF 600
- Cylite Pty. , Ltd.Mar 8, 2024
K231760 · HP-OCT (HP-OCT)
- Kowa Company , Ltd.Nov 21, 2022
K222372 · Kowa SL-19
- Medimaging Integrated Solution, Inc (Miis)Jan 14, 2020
K193188 · MiiS Horus Eye Anterior Camera
- Chongqing Sunkingdom Medical Instrument Co., Ltd.Nov 22, 2018
K182306 · Sunkingdom Slit Lamp
- Carl Zeiss Meditec, AGAug 24, 2018
K173771 · IOLMaster 700
- Chongqing Kanghua Ruiming S&T Co., Ltd.Dec 21, 2017
K171877 · SLM-1ER, SLM-2ER, SLM-3ER
- Medimaging Integrated Solution, Inc (Miis)Oct 6, 2017
K170470 · Digital Eye Anterior Camera