Recall Z-1367-2015
Nidek Inc · initiated March 6, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 80501 80522 80523 80524 80525 80526 80527 80540 80541 80542 80543 80544 80545 80546 80547 80548 80549 80552 80553 80554 80555 80556 80573 80574 80575 80576 80577 80578 80579 80580 80581 80582 80583 80584 80585 80586 80587 80615 80616 80617 80618 80619 80620 80621 80622 80623 80624 80625 80626 80627 80628 80629 80649 80650 80651 80652 80653…
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February.
Details
- Recall number
- Z-1367-2015
- Initiated
- March 6, 2015
- Posted by FDA
- April 2, 2015
- Terminated
- September 3, 2015
- Product code
- LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Quantity
- 799 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Nidek Inc, Fremont, CA