FDA Devices recall · Reported January 29, 2014
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Ziemer Usa Inc recalled 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated … - a moderate-severity action.
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated … was recalled by Ziemer Usa Inc in January 29, 2014. Reason: A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could…. Check the official notice for the remedy. Verify recall #Z-0811-2014 with the FDA Devices before acting.
The recall
Ziemer Usa Inc issued this moderate-severity FDA Devices recall-A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could….
- Moderate
- severity level
- 5 units
- affected scope
- Class II
- classification
- January 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0811-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
Reason for recall
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0811-2014 |
| Date reported | January 29, 2014 |
| Date initiated | April 16, 2013 |
| Recalling firm | Ziemer Usa Inc |
| Firm location | Alton, IL |
| Affected scope | 5 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany. |
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-0811-2014) 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.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026