Fargo Ortho-K Lens (PARAGON VISION SCIENCES, Inc) – manufactured lenses are not covered b... (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fargo Ortho-K Lens
Brand
PARAGON VISION SCIENCES, Inc
Lot Codes / Batch Numbers
All Lots, DI - B22208
Products Sold
All Lots, DI - B22208
PARAGON VISION SCIENCES, Inc is recalling Fargo Ortho-K Lens due to Manufactured lenses are not covered by existing FDA approval. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufactured lenses are not covered by existing FDA approval
Recommended Action
Per FDA guidance
On June 26, 2023, CooperVision on behalf of Paragon Vision Sciences issued an email communication indicating they had suspended U.S. Distribution. On July 26, 2023, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees via: letter or E-Mail. CooperVision asked consignees to take the following actions: 1. Existing patients should be transitioned from the iSee/Fargo product to an alternate treatment as soon as possible. 2. Identify appropriate alternate options for the patients. Potential alternative options include the, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees. following: " Different lenses, including those available from other manufacturers that you determine to be appropriate based on your assessment of patient suitability and treatment type. " Glasses that can provide the appropriate reduction in myopic refractive error for the patient, based on your assessment of patient suitability and treatment type. 3. During this transition time, current patients can continue to wear their lenses to continue their treatment. This includes continued access to replacement lenses as deemed necessary by you, the ECP, until the patient can be adequately refit and transitioned to a different product to continue their treatment. NOTE: This only applies to patients currently undergoing treatment with these lenses. No new patients will be provided access to these lenses. 4. Sign and return a copy of the attached Medical Device Correction Response Form acknowledging your receipt and understanding of the provided information. 5. Provide a copy of this letter to your patients. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026