Carl Zeiss Meditec AG

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
75
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1007-2022Class IIZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.March 16, 2022
Z-0723-2022Class IICIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlexJanuary 14, 2022
Z-2227-2021Class IIChassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"July 8, 2021
Z-1133-2021Class IIIOLMaster 700December 7, 2020
Z-0613-2021Class IICarl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refraAugust 6, 2020
Z-0614-2021Class IICarl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to deAugust 6, 2020
Z-0680-2020Class IIVisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjuncDecember 6, 2018
Z-0770-2020Class IIThe PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source October 16, 2018
Z-0108-2019Class IICarl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 June 25, 2018
Z-0001-2018Class IICarl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss MeAugust 30, 2017
Z-0357-2016Class IIIOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements andOctober 27, 2015
Z-0358-2016Class IIIOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometrOctober 27, 2015
Z-1049-2015Class IIFORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB FlashJanuary 22, 2015
Z-1153-2014Class IITreatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AGFebruary 3, 2014
Z-0333-2014Class IIZeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactureOctober 23, 2013
Z-0334-2014Class IIZeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactuOctober 23, 2013
Z-1440-2013Class IIZeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product NumbApril 18, 2013
Z-0405-2013Class IIINTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM October 25, 2012
Z-0404-2013Class IIINTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM October 25, 2012
Z-0406-2013Class IIINTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM October 25, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K243878CLARUS (700)April 17, 2025
K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRAJanuary 10, 2025
K233911VISULAS combiSeptember 6, 2024
K240215BLUE 400; BLUE 400 SJune 28, 2024
K233933CIRRUS™ HD-OCT Model 6000May 17, 2024
K233421RESCAN 700March 8, 2024
K232944CALLISTO eyeDecember 21, 2023
K232051VISULAS greenOctober 24, 2023
K230350VISULAS yagSeptember 22, 2023
K232159QEVO SystemSeptember 21, 2023
K231676CALLISTO eyeAugust 28, 2023
K230858QUATERA 700July 31, 2023
K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)June 20, 2023
K222200CIRRUS HD-OCTApril 13, 2023
K213527FORUMAugust 15, 2022
K211346BLUE 400July 22, 2022
K212241QUATERA 700April 19, 2022
K211156CONVIVO In Vivo Pathology SuiteDecember 29, 2021
K193376Visalis V500, Visalis S500June 15, 2020
K191194CLARUSJune 25, 2019