HPTClass I

Perimeter, Automatic, Ac-powered

Ophthalmic · 21 CFR 886.1605

MDR events3All time

Recalls1All time

Registered firms75Currently listed

510(k) clearances41All time

Recent MDR events

3 adverse event reports on file

Injury3

Reported product problem codes, most common first

Adverse Event Without Identified Device or Use Problem1

False Positive Result1

Incorrect, Inadequate or Imprecise Result or Readings1

Product Quality Problem1

Trend for “Adverse Event Without Identified Device or Use Problem”

No history to chart.

1 recall events for this product code

75 firms currently registered for this product code

41 clearances for this product code