GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator
Medical device recall Z-2120-2014. Published in FDA’s Enforcement Report on Aug 20, 2014.
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 Aug 20, 2014. 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
- 567 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?
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
567 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063 10064 10066 10067 10068 10072 10073 10074 10075 10079 10080 10081 10082 10083 10084 10085 10086 10087 10088 10108 10109 10110 10111…
Every code shown here, 1,995 characters
Model: GYC-1000; Serial numbers: 10018 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10063 10064 10066 10067 10068 10072 10073 10074 10075 10079 10080 10081 10082 10083 10084 10085 10086 10087 10088 10108 10109 10110 10111 10112 10113 10114 10115 10116 10117 10146 10147 10148 10149 10150 10151 10152 10153 10154 10155 10162 10208 10209 10212 10213 10222 10225 10226 10238 10239 10242 10243 10244 10245 10272 10273 10274 10275 10276 10295 10296 10297 10298 10299 10300 10301 10302 10303 10304 10328 10329 10330 10331 10332 10333 10334 10335 10336 10337 10356 10357 10358 10359 10360 10361 10362 10363 10364 10365 10366 10367 10400 10401 10402 10403 10404 10405 10406 10429 10430 10431 10432 10433 10459 10461 10464 10465 10466 10491 10492 10493 10494 10537 10538 10539 10540 10541 10542 10543 10544 10545 10546 10547 10548 10549 10550 10566 10567 10568 10569 10570 10571 10572 10573 10594 10595 10596 10597 10598 10599 10600 10608 10609 10610 10611 10612 10613 10614 10615 10616 10651 10652 10653 10654 10655 10673 10674 10675 10676 10677 10678 10679 10680 10696 10697 10732 10766 10767 10768 10769 10770 10771 10772 10773 10798 10799 10800 10801 10802 10821 10822 10823 10824 10825 10826 10827 10828 10854 10855 10856 10857 10858 10859 10860 10904 10905 10906 10907 10908 10909 10910 10911 10912 10913 10957 10958 10959 10960 10992 10993 10994 11080 11081 11082 11083 11084 11119 11120 11121 11122 11123 11155 11156 11157 11192 11193 11194 11195 11196 11197 11198 11199 11236 11237 11238 11239 11240 11241 11242 11243 11244 11245 11261 11262 11263 11270 11271 11272 11273 11310 11311 11312 11313 11314 11315 11316 11317 11318 11319 11367 11368 11369 11370 11371 11372 11373 11406 11407 11408 11409 11410 11411 11412 11449 11450 11451 11568 11569 11601 11602 11603 11604 11605 11630 11631 11632 11633 11634 11635 11636 11637 11660 11661 11662 11663 11664 11724 11725 11726 11727 11728 11769 11770 11771 11791 11792 11793 11817 11818 11819 11820 11821 11863 11864 11865 11866 11867…
FDA’s list runs to 3,351 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.
USA (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 May 16, 2014.
- FDA classified it on Aug 13, 2014.
- FDA’s Enforcement Report published it on Aug 20, 2014.
- FDA terminated it on Oct 16, 2014.
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 3,351 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.