Z-0988-2015Class II

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries

Name: Z-0988-2015 Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries
Creator: Ziemer Usa Inc
Published: 2014-12-18
License: https://open.fda.gov/license/

Ziemer USA Inc / initiated 2014-12-18 / Terminated / root cause: labeling and UDI

FDA source

Ziemer Usa Inc began a recall of Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries on 2014-12-18. FDA classified it as Class II and gives the reason as "The devices were not shipped with the Starter Kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0988-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Posted: 2015-01-15
Terminated: 2018-02-20
Recalling firm: Ziemer USA Inc
Product: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Product code: HQF Laser, Ophthalmic
Reason for recall: The devices were not shipped with the Starter Kits.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Notification letters dated December 18, 2014 were sent to all direct account s(customers). The letters were included with the Starter Kit referred to in the Surgical Procedure Manual.
Quantity in commerce: 26 lasers
Distribution: US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Product codes and lots: Serial Numbers: FLM4184, FLM2003, FLM3324, FLM1409, FLM2906, FLM2136, FLM4948, FLM3134, FLM4587, FLM3281, FLM2179, FLM1467, FLM1239, FLM3361, FLM3319, FLM3685, FLM2915, FLM1230, FLM3229, FLM4094, FLM4135, FLM4545, FLM4905, FLM3913, FLM1680, FLM1776

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code HQF

K131207Class IIFemto Ldv(tm) Z-Generation Femtosecond Surgical LaserSurgical Instrument Engineering AG / cleared 2013-10-09

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)