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AcuFocus, Inc. recalls KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for
Recalled March 30, 2016 · FDA recall Z-1235-2016 · AcuFocus
Hazard
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. · FDA Class II
Units
182 units
Sold at
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
Description
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Product
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.
Manufacturer(s)
AcuFocus, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →