LXSClass II

Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Ophthalmic · 21 CFR 886.4392

MDR events68All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances6All time

Recent MDR events

68 adverse event reports on file

Event type breakdown

Malfunction61

Injury5

Other2

Most-reported manufacturers

Nidek Co., Ltd.15 Alcon - Irvine Technology Center10 Nidek Co., Ltd8 Hoya Conbio6 Nidek Co. Ltd.6 Alcon Laboratories, Inc.4 Alcon-irvine Technology Center3 Nidek Co., Ltd. Hamacho Plant3

Recalls

1 recall events for this product code

Nidek Inc
TerminatedApr 2, 2015
YC-1800 OPHTHALMIC YAG LASER SYSTEM;
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.
Z-1367-2015 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

6 clearances for this product code