The Recall Desk

Manufacturer

Opternative Inc

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2019-08-14

Of the 1 recalls from Opternative 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-2223-2019·2019-08-14

    Opternative Recalls Visibly Online Refractive Vision Test Software

    Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.

    Product
    The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision ref
    Category
    Medical Device
    Distribution
    Distributed nationwide