Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 19, 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 undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carl Zeiss Meditec Ag recalled Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss… - a moderate-severity action.
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss… was recalled by Carl Zeiss Meditec Ag in March 19, 2014. Reason: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.. Check the official notice for the remedy. Verify recall #Z-1153-2014 with the FDA Devices before acting.
The recall
Carl Zeiss Meditec Ag issued this moderate-severity FDA Devices recall-Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S..
- Moderate
- severity level
- Class II
- classification
- March 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1153-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1153-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on February 3, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Carl Zeiss Meditec Ag is listed as the recalling firm, operating out of Jena, N/A. Federal records list the affected scope as 1 package containing 10 individual treatment packs.
The documented reason for this recall is: Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Distribution data in the federal record shows the product reached: US Distribution: NV only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 package containing 10 individual treatment packs
Related Recalls
6
3 from same agency
Product description
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 undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
Reason for recall
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1153-2014 |
| Date reported | March 19, 2014 |
| Date initiated | February 3, 2014 |
| Recalling firm | Carl Zeiss Meditec Ag |
| Firm location | Jena, N/A |
| Affected scope | 1 package containing 10 individual treatment packs |
| Distribution | US Distribution: NV only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1153-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.. Recalled by Carl Zeiss Meditec Ag. Units affected: 1 package containing 10 individual treatment packs.
Why was this product recalled? ▼
Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1153-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution: NV only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1153-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.