The Recall Desk

Manufacturer

PARAGON VISION SCIENCES, Inc

2 recalls in our database name PARAGON VISION SCIENCES, Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-09-13

Of the 2 recalls from PARAGON VISION SCIENCES, 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.

1–2 of 2

  • HighFDA (Devices)·Z-2515-2023·2023-09-13

    ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval

    Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.

    Product
    ISee Ortho-K Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2023·2023-09-13

    Fargo Ortho-K Contact Lens Recall Due to Missing FDA Approval

    PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.

    Product
    Fargo Ortho-K Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide