Z-1235-2016 Class II Terminated
FDA device recall Z-1235-2016 was initiated by AcuFocus, Inc. on February 11, 2016 and is designated Class II. Reason for recall: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The recall status is terminated (terminated May 4, 2016). Affected quantity: 182 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2016
- Initiation Date
- February 11, 2016
- Termination Date
- May 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182 units
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.
Reason for Recall
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Distribution Pattern
International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
Code Information
Lots A534-1014 and A535-1014