Device 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.
Z-1235-2016
Product summary
- Firm
- AcuFocus, Inc.
- Event
- Event 73343
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182 units
- Official record key
device-enforcement:Z-1235-2016
Official wording
Reason: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Code information: Lots A534-1014 and A535-1014
Distribution pattern: International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.