FDAFebruary 11, 2016device

KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.

What to do

FDA enforcement status: Terminated

Brands named

acufocus

Recall history

No related federal recalls on record for this brand yet.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →