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.
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