Devices

Device Recall KAMRA INLAY

Model / Serial
Lots A534-1014 and A535-1014
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
Yes
Distribution
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
Product Description
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.
Manufacturer
AcuFocus, Inc.
1 Event
- Recall of Device Recall KAMRA INLAY

Manufacturer

AcuFocus, Inc.

Manufacturer Address
AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
Manufacturer Parent Company (2017)
AcuFocus Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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