Device 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.
Z-1710-2015
Product summary
- Firm
- Nidek Inc
- Event
- Event 71098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 units
- Official record key
device-enforcement:Z-1710-2015
Official wording
Reason: Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Code information: Alll devices currently in use by consignees.
Distribution pattern: Us distribution only.
Derived failure modes
-
Unknown
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.