Recall Z-1710-2015 ยท LZS Excimer Laser System
Nidek Inc
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.
| Date | Jun 4, 2015 (initiated Mar 24, 2015) |
| Status | Terminated |
| Reason | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. |
| Root cause | No Marketing Application |
| Action | Nidek sent an Device Correction letter dated April 30th, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Nidek will contact customers to schedule an appointment to replace the operators manual and implementing a software lockout device on the device so that the multi stage feature is no longer available. If a Nidek rep does not contact you before April 30, 2015, please call 800-223-9044 to schedule an appointment, All non responding customers.will be contacted three time via Fed Ex letter |
| Quantity | 114 units |
| Distribution | Us distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.