Z-0811-2014Class II

1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the...

Name: Z-0811-2014 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the...
Creator: Ziemer Usa Inc
Published: 2013-04-16
License: https://open.fda.gov/license/

Ziemer USA Inc / initiated 2013-04-16 / Terminated / root cause: design

FDA source

Ziemer Usa Inc began a recall of 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... on 2013-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0811-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-16
Posted: 2014-01-23
Terminated: 2017-12-27
Recalling firm: Ziemer USA Inc
Product: 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.
Product code: HQF Laser, Ophthalmic
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: A recall notification letter dated April 16, 2013 was mailed to direct accounts. The letter notified the direct accounts of the problem and advised them that a technician would be arriving at their facility during the week of June 2, 2013 to replace the defective controller board. The technician will also perform preventative maintenance on the device at the same time. Direct accounts are advised to contact Ziemer USA, Inc. at 618-462-9301 if they have any questions about this issue.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
Product codes and lots: Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0811-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code HQF

K112154Class IIFemto LdvSie Ag,Surgical Instument Engineering / cleared 2012-03-16

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)