FDA Recall
Terminated
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Recall: Z-0988-2015
·
Initiated December 18, 2014
Recall
- Recall Number
- Z-0988-2015
- Event Number
- 70024
- Firm
- Ziemer Usa Inc
- FEI Number
- 3006231532
- Product Code
- HQF
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- December 18, 2014
- Posted
- January 15, 2015
- Terminated
- February 20, 2018
- Address
- 620 East Third Street, Alton, IL, 62002
Description
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
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.
Distribution
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Quantity
26 lasers