YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for out
FDA device recall Z-1367-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- 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.
- Action taken
- Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXS
- Quantity affected
- 799 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-03-06
- Date posted
- 2015-04-02
- Date terminated
- 2015-09-03
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIDEK MODEL YC-1200 (K893987) | Nidek, Inc. | 1989-08-18 |