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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 18,820
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
Part of a larger recall action
This product is one of 2 recalled by PARAGON VISION SCIENCES, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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