openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
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.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
