Reported Jun 10, 2015 · Terminated
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest
- OpthalmicNIDEK 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
- Lot codes and dates
- Alll devices currently in use by consignees.
- Amount recalled
- 114 units
Why it was recalled
Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Nidek Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.