Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
FDA Recall #Z-0988-2015 — Class II — December 18, 2014
Product Description
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Reason for Recall
The devices were not shipped with the Starter Kits.
Recalling Firm
Ziemer Usa Inc — Alton, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 lasers
Distribution
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated