Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ISee Ortho-K Lens Recalled by PARAGON VISION SCIENCES, Inc Due to Manufactured lenses are not covered by existing FDA...

Date: June 26, 2023
Company: PARAGON VISION SCIENCES, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact PARAGON VISION SCIENCES, Inc directly.

Affected Products

ISee Ortho-K Lens

Quantity: 83,542 lenses

Why Was This Recalled?

Manufactured lenses are not covered by existing FDA approval

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About PARAGON VISION SCIENCES, Inc

PARAGON VISION SCIENCES, Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report