Food, drugs, devices › Carl Zeiss Meditec AG
Device recall: Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The Vis
Carl Zeiss Meditec AG (Jena, N/A) initiated this device recall on 3 Feb 2014; FDA lists 1 product record under event 67440, 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 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 7 Mar 2014. 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
"Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S."
Distribution
"US Distribution: NV only."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1153-2014 | Treatment 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… | 1 package containing 10 individual treatment packs | Class II | Terminated | 19 Mar 2014 |
Context
Other enforcement events for Carl Zeiss Meditec AG
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: "Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S."
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: "US Distribution: NV only."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Mar 2014. "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.