Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
FDA Recall Z-0988-2015 · Posted 2015-01-15
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Recalling FirmZiemer Usa Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2014-12-18
Date Terminated2018-02-20
Product Quantity26 lasers
Reason for Recall
The devices were not shipped with the Starter Kits.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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