KAMRA Inlay recall
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…
Why was KAMRA Inlay recalled?
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots A534-1014 and A535-1014
- 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…
- Recalling firm
- AcuFocus, Inc.
- Quantity
- 182 units
- Distribution
- International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
- Recall date
- March 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)