Carl Zeiss Meditec, Inc.

• OBO — Ophthalmic8 devices
• HLI — Ophthalmic7 devices
• QER — Ophthalmic3 devices
• JAD — Radiology2 devices
• MYC — Ophthalmic2 devices
• NFJ — Radiology2 devices
• HJO — Ophthalmic1 device
• HNO — Ophthalmic1 device
• HPT — Ophthalmic1 device
• HQF — Ophthalmic1 device

• Z-0723-2022 — CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlexClass II·Ongoing·2022-01-14
• Z-2227-2021 — Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"Class II·Ongoing·2021-07-08
• Z-0680-2020 — VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.Class II·Terminated·2018-12-06
• Z-0770-2020 — The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.Class II·Terminated·2018-10-16
• Z-0333-2014 — Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantationClass II·Terminated·2013-10-23
• Z-0334-2014 — Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantationClass II·Terminated·2013-10-23
• Z-1440-2013 — Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.Class II·Terminated·2013-04-18
• Z-0405-2013 — INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.Class II·Terminated·2012-10-25
• Z-0404-2013 — INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatmentsClass II·Terminated·2012-10-25
• Z-0406-2013 — INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.Class II·Terminated·2012-10-25

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K243878 — CLARUS (700)Code QER·2025-04-17
• K233933 — CIRRUS HD-OCT Model 6000Code OBO·2024-05-17
• K230350 — VISULAS yagCode HQF·2023-09-22
• K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Code IZI·2023-06-20
• K222200 — CIRRUS HD-OCTCode OBO·2023-04-13
• K191194 — CLARUSCode QER·2019-06-25
• K181534 — CIRRUS HD-OCTCode OBO·2019-02-15
• K181444 — CLARUSCode QER·2019-01-10
• K182318 — Retina WorkplaceCode NFJ·2018-10-24
• K173371 — VisuMax Femtosecond LaserCode HNO·2018-04-13
• K161194 — PLEX Elite 9000 SS-OCTCode OBO·2016-10-26
• K150977 — CIRRUS HD-OCTCode OBO·2015-09-01
• K143275 — IOLMaster700Code HJO·2015-07-10
• K130549 — INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORCode JAD·2013-06-26
• K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSCode JAD·2012-12-27
• K112184 — CIRRUS PHOTOCode OBO·2012-06-18
• K111157 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASESCode OBO·2012-01-19
• K093213 — GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCode HPT·2010-03-12
• K093521 — GDXPROCode MYC·2009-11-25
• K082016 — GDX VCC WITH ECC SOFTWARECode MYC·2009-08-10
• K083291 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000Code OBO·2009-05-05
• K090439 — FORUMCode NFJ·2009-03-25
• K063378 — CIRRUS HD-OCT, MODEL 4000Code HLI·2007-01-26
• K051789 — VISANTE OCTCode HLI·2005-09-30
• K033123 — STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASECode HLI·2004-04-20
• K030433 — STRATUSOCT WITH RNFL NORMATIVE DATABASECode HLI·2003-05-01
• K951132 — ANGIOSCAN (AS STAND ALONE INSTRUMENT)Code HLI·1995-06-26
• K941705 — NERVE FIBER ANALYZERCode HLI·1994-07-18
• K923742 — TOPOGRAPHIC SCANNING SYSTEM TOPSSCode HLI·1993-03-26