Reported Nov 26, 2014 · Terminated
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a 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?
- Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
- Lot codes and dates
- Serial numbers
530054530055530070530073530078530082530086530087530098530106530121530123530150530155
- Serial numbers
- Amount recalled
- 14 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
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.
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