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Kamra Corneal Inlay ACI 7000 (2015-04-07)
- Starting date:
- April 7, 2015
- Posting date:
- April 30, 2015
- 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-53181
Recalled Products
A. Kamra Corneal Inlay ACI 7000
Reason
Field safety notice adds the following additional recommendation to IFU: "While no issues have been reported, removal of the inlay prior to any laser-based glaucoma therapy is recommended ".
Affected products
A. Kamra Corneal Inlay ACI 7000
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ACI 7000
Companies
- Manufacturer
-
Acufocus Inc.
32 Discovery, Suite 200
Irvine
92618
California
UNITED STATES