RecallRadar

FDA Device recall Z-1367-2015

YC-1800 OPHTHALMIC YAG LASER SYSTEM

On 2015-04-08 the FDA classified a Class II recall of YC-1800 OPHTHALMIC YAG LASER SYSTEM by Nidek, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1367-2015
ClassificationClass II
Statusterminated
Initiated2015-03-06
Published2015-04-08
Last updated2026-09-13 11:53 UTC
CompanyNidek
DistributionUS

Product

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.

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.

Identifiers

code_info
Serial numbers: 80007 80008 80009 80010 80011 80012 80013 80014 80015 80016 80017 80018 80019 80020 80021…Serial numbers: 80007 80008 80009 80010 80011 80012 80013 80014 80015 80016 80017 80018 80019 80020 80021 80042 80043 80044 80045 80046 80047 80048 80049 80050 80051 80052 80053 80054 80055 80056 80077 80078 80079 80080 80081 80082 80083 80084 80085 80086 80087 80088 80089 80090 80091 80113 80114 80115 80116 80117 80118 80119 80120 80121 80122 80123 80124 80125 80129 80154 80155 80156 80157 80158 80159 80160 80161 80162 80163 80185 80186 80187 80188 80189 80190 80191 80192 80218 80219 80220 80221 80223 80224 80225 80255 80256 80257 80258 80259 80260 80261 80262 80263 80264 80290 80291 80292 80293 80294 80295 80296 80297 80327 80328 80329 80330 80331 80332 80333 80334 80335 80336 80337 80338 80339 80340 80341 80384 80385 80386 80387 80388 80389 80390 80391 80392 80393 80395 80417 80418 80419 80420 80421 80440 80441 80442 80443 80444 80445 80446 8050

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2015%22

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