CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report
Excimer Laser Corneal Surgery System recalled by Nidek
Nidek is recalling Nidek Excimer Laser Corneal Surgery System, distributed in 10 states. The recall was initiated on 6 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0223-2015
- FDA event ID
- 69508
- Recalling firm
- Nidek, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2012
- FDA classified
- 17 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2012 | Recall initiated by company | |
| 17 Nov 2014 | Classified by FDA | +833 days |
| 26 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
ArizonaCaliforniaColoradoConnecticutFloridaLouisianaMaineMichiganMissouriNew York
Questions about this recall
Is Excimer Laser Corneal Surgery System recalled?
Yes. Nidek recalled Excimer Laser Corneal Surgery System on 6 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0223-2015.
Why was it 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.
Which lots are affected?
Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155
Where was it sold?
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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