Recall Register

Carl Zeiss Meditec AG: FDA recalls

FDA enforcement reports name Carl Zeiss Meditec AG as the recalling firm in 9 events. The events have 11 product records. The recalls started from 2014 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of Carl Zeiss Meditec AG
InitiatedProduct (first record)TypeClassRecordsStatus
1 Jun 2026Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557DeviceClass II1Ongoing
16 Mar 2022ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.DeviceClass II1Ongoing
7 Dec 2020IOLMaster 700DeviceClass II1Terminated
6 Aug 2020Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.DeviceClass II2Terminated
25 Jun 2018Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01DeviceClass II1Terminated
30 Aug 2017Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatmentsDeviceClass II1Terminated
27 Oct 2015IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.DeviceClass II2Terminated
22 Jan 2015FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management…DeviceClass II1Terminated
3 Feb 2014Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Carl Zeiss Meditec AG: events for each product type
TypeEvents
Device9
Carl Zeiss Meditec AG: events in each class
ClassEvents
Class II9
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Carl Zeiss Meditec AG, by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Carl Zeiss Meditec AG: FDA recalls. https://recallregister.com/firm/carl-zeiss-meditec-ag/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Carl Zeiss Meditec AG have?
Class II: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Carl Zeiss Meditec AG?
FDA event 99239, which the firm started on 1 Jun 2026. The first product in the record is: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
How many FDA recalls of Carl Zeiss Meditec AG have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.