The Recall Desk
HighFDA (Devices)·Z-2516-2023·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Contact lenses are risk-of-harm medical devices. These lenses lack required FDA approval, meaning their safety and quality standards were not verified through regulatory review. No illnesses or injuries have been reported, but the unapproved status represents a theoretical risk-of-harm situation.

Plain-English summary

PARAGON VISION SCIENCES, Inc. is recalling Fargo Ortho-K contact lenses (all lots, Device Identifier B22208). The lenses were manufactured without coverage under existing FDA approval.

Approximately 18,820 lenses were distributed worldwide, including across all U.S. states and territories and to Australia, Canada, China, Japan, and Vietnam.

Patients currently wearing these lenses should contact their eye care provider immediately to discuss alternative vision correction options.

The recalled product

Product
Fargo Ortho-K Lens
Manufacturer
PARAGON VISION SCIENCES, Inc
Category
Medical Device — Vision / Contact Lens
Hazard
  • regulatory-non-compliance
  • unapproved-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All Lots
  • DI - B22208

Distribution

Distributed nationwide across the United States.

Related recalls

Same category