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KAMRA CORNEAL INLAY ACI 7000 (2016-02-11)
- Starting date:
- February 11, 2016
- Posting date:
- February 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57214
Affected Products
KAMRA CORNEAL INLAY ACI 7000
Reason
Due to a secondary processing which occurred during the manufacture of these units, an incorrect shelf life was assigned to the product. The incorrect labelled expiry date does not pose a patient safety risk based on data available; however, in an abundance of caution, AcuFocus is retrieving the two (2) lots of KAMRA inlays from the market. No other lots of KAMRA inlays manufactured and distributed by AcuFocus are affected by this recall action.
Affected products
KAMRA CORNEAL INLAY ACI 7000
Lot or serial number
A534-1014
A535-1014
Model or catalog number
ACI 7000
Companies
- Manufacturer
-
Acufocus Inc.
32 Discovery, Suite 200
Irvine
92618
California
UNITED STATES