YC-1800 OPHTHALMIC YAG LASER SYSTEM
Medical device recall Z-1367-2015. Published in FDA’s Enforcement Report on Apr 8, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 799 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
799 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 80654 80655 80656 80657 80658 80659 80660 80661 80662 80663 80689 80690 80691 80692 80693 80694 80695 80696 80697 80698 80731 80732 80733 80734 80735 80736 80737 80738 80739 80740 80741 80770 80771 80772 80773 80774 80775 80776 80777 80778 80779 80780 80809 80810 80811 80812 80813 80814 80815 80816 80817 80818 80819 80820 80821 80822 80823 80846 80847 80848 80849 80850 80851 80852 80959 80960 80961 80962 80963 80996 80997 80998 81037 81038 81039 81040 81041 81042 81043 81044 81045 81046 81081 81082 81083 81084 81085 81086 81087 81088 81089 81090 81092 81093 81094 81095 81122 81123 81124 81125 81126 81127 81128 81129 81130 81131 81170 81171 81172 81173 81174 81175 81176 81177 81178 81179 81180 81181 81182 81183 81184 81226 81227 81228 81229 81230 81231 81232 81279 81280 81281 81338 81339…
FDA’s list runs to 5,152 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 6, 2015.
- FDA classified it on Apr 2, 2015.
- FDA’s Enforcement Report published it on Apr 8, 2015.
- FDA terminated it on Sep 3, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Nidek Inc, of Fremont, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,152 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.