YC-1800 OPHTHALMIC YAG LASER SYSTEM — Class II medical device recall Z-1367-2015
Terminated recall by Nidek Inc, reported 2015-04-08, distributed nationwide. Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safe
| Recall number | Z-1367-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc, Fremont, CA, United States |
| Recall initiated | 2015-03-06 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 799 units |
| 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 and 475 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1367-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.