Product Wiki · Recalls · Health Canada — Medical Devices

KAMRA CORNEAL INLAY ACI 7000 (2016-02-11) — recall 54940

Health Canada — Medical Devices · Canada · 2016-02-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
54940
Date of alert
2016-02-22
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/kamra-corneal-inlay-aci-7000-2

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