Class 2 Device Recall Ziemer Femto LDV ZGeneration Femtosecond Surgical Lasers

• Date Initiated by Firm: December 18, 2014
• Date Posted: January 15, 2015
• Recall Status: Terminated on February 20, 2018
• Recall Number: Z-0988-2015
• Recall Event ID: 70024
• 510(K)Number: K131207
• Product Classification: Laser, ophthalmic - Product Code HQF
• Product: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
• 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
• Recalling Firm/ Manufacturer: Ziemer Usa Inc; 620 East Third Street; Alton IL 62002
• For Additional Information Contact: Ms. Angela Braida; 618-462-9301
• Manufacturer Reason for Recall: The devices were not shipped with the Starter Kits.
• FDA Determined 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)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HQF and Original Applicant = SURGICAL INSTRUMENT ENGINEERING AG