Recall Z-1367-2015 ยท LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Nidek Inc
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.
| Date | Apr 2, 2015 (initiated Mar 6, 2015) |
| Status | Terminated |
| Reason | Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images. |
| Root cause | Process control |
| Action | Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February. |
| Quantity | 799 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893987 | NIDEK MODEL YC-1200 Nidek, Inc., Aug 18, 1989 |