Food, drugs, devices › Carl Zeiss Meditec AG

Device recall: FORUM 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). Catalo

FDA enforcement event 70365 · Class II · initiated 22 Jan 2015 · status Terminated · terminated 4 Mar 2016

DeviceVoluntary: Firm initiated1 product recordJena, N/A

Carl Zeiss Meditec AG (Jena, N/A) initiated this device recall on 22 Jan 2015; FDA lists 1 product record under event 70365, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 4 Mar 2016. Initiation: voluntary: firm initiated. Carl Zeiss Meditec AG has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Carl Zeiss Meditec AG, Jena, N/A, Germany.

Reason for recall

"Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data."

Distribution

"Nationwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1049-2015	FORUM 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…	985	Class II	Terminated	11 Feb 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Carl Zeiss Meditec AG

Initiated	Product (first record)	Type	Class	Records
1 Jun 2026	Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557	Device	Class II	1
16 Mar 2022	ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.	Device	Class II	1
7 Dec 2020	IOLMaster 700	Device	Class II	1
6 Aug 2020	Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of conta	Device	Class II	2
25 Jun 2018	Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01	Device	Class II	1
30 Aug 2017	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germa	Device	Class II	1
27 Oct 2015	IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations t	Device	Class II	2
3 Feb 2014	Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The Vis	Device	Class II	1

All 9 events for Carl Zeiss Meditec AG

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Mar 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.