CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
The Femto LDV Z2 Femtosecond Surgical Laser recalled by Ziemer Usa
Ziemer Usa is recalling The Femto LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for, distributed nationwide in the US. The recall was initiated on 16 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0811-2014
- FDA event ID
- 64966
- Recalling firm
- Ziemer Usa, Alton, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 16 Apr 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +282 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817
Where was it sold?
Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ziemer Usa
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Femto LDV Z-Generation Femtosecond Surgical Lasers are used recalled | Ziemer Usa | Other | Nationwide |
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