AcuFocus, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1235-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 11, 2016

Date Posted: March 30, 2016

Recall Number: Z-1235-2016

Event ID: 73343

Reason for Recall:

AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.

Status: Terminated

Product Quantity: 182 units

Code Information:

Lots A534-1014 and A535-1014

Distribution Pattern:

International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated