Recall Z-0988-2015 ยท HQF Laser, Ophthalmic
Ziemer Usa Inc
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
| Date | Jan 15, 2015 (initiated Dec 18, 2014) |
| Status | Terminated |
| Reason | The devices were not shipped with the Starter Kits. |
| Root 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 | 26 lasers |
| Distribution | US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131207 | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER Surgical Instrument Engineering AG, Oct 9, 2013 |