Device, Analysis, Anterior Segment
Ophthalmic · 21 CFR 886.1850
Recent MDR events
12 adverse event reports on file
- OCULUS PENTACAMNov 7, 2025MalfunctionOculus Optikgerate GmbhMW5178635
- WAVELIGHT OCULYZER II DIAGNOSTIC DEVICESep 26, 2024MalfunctionWavelight Gmbh3003288808-2024-00251
- ALLEGRO OCULYZERSep 22, 2020MalfunctionWavelight Gmbh3003288808-2020-00548
- GALILEI G6 LENS PROFESSIONALJun 8, 2020InjurySis Ltd., Surgical Instrument Systems9614468-2020-00001
- ALLEGRO OCULYZERDec 16, 2019MalfunctionWavelight Gmbh3003288808-2019-01236
- ALLEGRO OCULYZERNov 27, 2019MalfunctionWavelight Gmbh3003288808-2019-01171
- ALLEGRO OCULYZERAug 27, 2018MalfunctionWavelight Gmbh3003288808-2018-01514
- ALLEGRO OCULYZERJun 7, 2018InjuryWavelight Gmbh3003288808-2018-01086
- ALLEGRO OCULYZEROct 23, 2017MalfunctionWavelight Gmbh3003288808-2017-02276
- ALLEGRO OCULYZEROct 20, 2017MalfunctionWavelight Gmbh3003288808-2017-02254
Event type breakdown
Most-reported manufacturers
Recalls
7 recall events for this product code
- Oculus Optikgeraete GMBHOpen, ClassifiedAug 30, 2023
Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Z-2482-2023 · View FDA record ↗ - Oculus Optikgeraete GMBHOpen, ClassifiedAug 30, 2023
Oculus Pentacam AXL , Ref 70100, CE 0123
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Z-2483-2023 · View FDA record ↗ - Oculus Optikgeraete GMBHOpen, ClassifiedAug 30, 2023
Oculus Myopia Master , Ref 68100, CE 0123
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Z-2484-2023 · View FDA record ↗ - Oculus Optikgeraete GMBHTerminatedUnknown
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germ
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Z-0635-2018 · View FDA record ↗ - Oculus Optikgeraete GMBHOpen, ClassifiedUnknown
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1672-2022 · View FDA record ↗ - Oculus Optikgeraete GMBHOpen, ClassifiedUnknown
Pentacam AXL REF 70100,
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1673-2022 · View FDA record ↗ - Oculus Optikgeraete GMBHOpen, ClassifiedUnknown
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Z-1674-2022 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Oculus Florida Service Center
Port Saint Lucie, FL, US
S4optik Llc
Jacksonville, FL, US
Essilor International Usine De La Compasserie
Ligny en Barrois Meuse, FR
Luneau Technology Operations
Pont-de-l'Arche Eure, FR
Santec Ois Corporation
Komaki Aichi, JP
Topcon Corp.
TOKYO, JP
Ziemer Ophthalmic Systems Ag
PORT Bern, CH
Ziemer Opthalmic Systems Ag
Bruegg Bern, CH
Oculus Optikgerate Gmbh
WETZLAR Hesse, DE
Eurofins Steripac Gmbh
Calw-Altburg Baden-Wurttemberg, DE
Oculus, Inc.
Arlington, WA, US
Topcon Yamagata Co., Ltd
Yamagata-KEN, JP
510(k) clearances
23 clearances for this product code
- Oculus Optikgeräte GmbHMar 13, 2026
K251848 · Pentacam® Cornea OCT
- Tomey CorporationDec 18, 2025
K252348 · Tomey Optical Biometer OA-2000 (OA-2000)
- Intelon Optics, Inc.Aug 16, 2024
K223700 · BOSS
- Visia Imaging S.R.L.Jun 29, 2023
K222933 · MYAH
- Visia Imaging S.R.L.Mar 1, 2022
K211868 · MYAH
- Oculus Optikgeräte GmbHJul 14, 2021
K202989 · Myopia Master
- Oculus Optikgerate GmbHOct 21, 2020
K201724 · Pentacam AXL Wave
- Sis Ag, Surgical Instrument SystemsJul 25, 2019
K182659 · Galilei G6 Lens Professional