The Recall Desk

Manufacturer

AcuFocus, Inc.

1 recall in our database name AcuFocus, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2016-03-30

Of the 1 recalls from AcuFocus, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1235-2016·2016-03-30

    AcuFocus Recalls KAMRA Corneal Inlays Due to Shelf Life Labeling Concerns

    AcuFocus is recalling 182 KAMRA ACI 7000 Corneal Inlays because of concerns regarding the labeled shelf life. The devices were distributed in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states