Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-1235-2016

U.S. FDA — Device Enforcement · United States · 2016-02-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1235-2016
Date of alert
2016-02-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
AcuFocus, Inc.
Product category
device
Product type
Devices
Reported risk: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.