Nidek YC-1800 Ophthalmic YAG Laser System Recalled for Pitting Lens
Nidek Inc is recalling 799 YC-1800 Ophthalmic YAG Laser Systems due to complaints of pitting lenses that may cause unclear images.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves pitting lenses causing unclear images, which is a functional defect without reported injuries or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Nidek Inc is recalling 799 units of the YC-1800 Ophthalmic YAG Laser System. The device is used for the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by the energy of YAG laser pulses. The recall is being conducted due to complaints of pitting lenses that may cause unclear images.
The affected units were distributed nationwide. The recall is classified as Class II by the FDA. Nidek Inc is sending a Dear Doctor letter and a Quick Reference Guide to users of the YC-1800 to reiterate important safety and cleaning information.
The recalled product
- 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.
- Manufacturer
- Nidek Inc
- Affected units
- 799
Distribution
Distributed nationwide across the United States.
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