Recall Z-1235-2016— AcuFocus, Inc.
Class II · Terminated
Class II FDA medical device recall by AcuFocus, Inc., initiated 2016-02-11, terminated 2016-05-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life..
- Recalling firm
- AcuFocus, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-11
- Terminated
- 2016-05-04
- Firm location
- Irvine, CA, United States
Product description
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.
Reason for recall
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.