Events

Recall of Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ziemer Usa Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70024
  • Event Risk Class
    Class 2
  • Event Number
    Z-0988-2015
  • Event Initiated Date
    2014-12-18
  • Event Date Posted
    2015-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132124
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laser, ophthalmic - Product Code HQF
  • Reason
    The devices were not shipped with the starter kits.
  • 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.

Device

Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers
  • Model / Serial
    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
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
  • Product Description
    Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
  • Manufacturer
    Ziemer Usa Inc

Manufacturer

Ziemer Usa Inc
  • Manufacturer Address
    Ziemer Usa Inc, 620 East Third Street, Alton IL 62002
  • Manufacturer Parent Company (2017)
    Ziemer Holding Ag
  • Source
    USFDA