EC-5000 Excimer Laser Corneal Surgery System recall
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model…
Why was EC-5000 Excimer Laser Corneal Surgery System recalled?
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Alll devices currently in use by consignees.
- Product
- EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model…
- Recalling firm
- Nidek Inc
- Quantity
- 114 units
- Distribution
- Us distribution only.
- Recall date
- June 10, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)