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.

Recall Insight

This FDA Devices action (record #Z-1367-2015) was formally reported on April 8, 2015, with the manufacturer initiating the action on March 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Nidek Inc is listed as the recalling firm, operating out of Fremont, CA. Federal records indicate 799 units units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.