AcuFocus, Inc.

FDA Regulatory Profile

AcuFocus, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1235-2016, Class II) was initiated on February 11, 2016.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1235-2016Class IIKAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlFebruary 11, 2016