Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature
Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.
What this means for you
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, but the source text explicitly states the issue is an unapproved manual feature without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Nidek Inc is recalling 114 units of the EC-5000 Excimer Laser Corneal Surgery System, including models EC-5000, EC 5000 CXIII, and EC-5000 Quest. These ophthalmic laser systems are used for the correction of corneal refraction and ablation of the corneal surface. The recall is limited to the United States distribution.
The reason for the recall is that the multi-stage treatment option described in the EC-5000 Operator's Manual was not approved by the FDA. The source text does not report any illnesses, injuries, or deaths associated with this issue.
All 114 devices are currently in use by consignees. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, nor does it specify a date for the recall.
The recalled product
- Product
- EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
- Manufacturer
- Nidek Inc
- Hazard
- Affected units
- 114
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Alll devices currently in use by consignees.
Distribution
Distribution scope not specified by the agency.
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