FDA-Device2016-03-30Class II
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.
AcuFocus, Inc.
Hazard
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Sold states
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
Affected count
182 units
Manufactured in
32 Discovery Ste 200, N/A, Irvine, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2016Don't want to check this manually?
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