FDA Device recall Z-1710-2015
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest by Nidek, citing multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1710-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-24 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek |
| Distribution | n/a |
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.
Reason
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
Identifiers
| code_info | Alll devices currently in use by consignees. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1710-2015%22
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