Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
KAMRA Inlay Recalled by AcuFocus, Inc. Due to AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AcuFocus, Inc. directly.
Affected Products
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.
Quantity: 182 units
Why Was This Recalled?
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Where Was This Sold?
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
About AcuFocus, Inc.
AcuFocus, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report