Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1367-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-03-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1367-2015
Date of alert: 2015-03-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nidek Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1367-2015 — 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.

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