Z-2516-2023Class II

Fargo Ortho-K Lens

Name: Z-2516-2023 Fargo Ortho-K Lens
Creator: PARAGON VISION SCIENCES, Inc
Published: 2023-06-26
License: https://open.fda.gov/license/

Paragon Vision Sciences, Inc. / initiated 2023-06-26 / Open, Classified / root cause: manufacturing process

FDA source

PARAGON VISION SCIENCES, Inc began a recall of Fargo Ortho-K Lens on 2023-06-26. FDA classified it as Class II and gives the reason as "Manufactured lenses are not covered by existing FDA approval". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2516-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-26
Posted: 2023-09-05
Recalling firm: Paragon Vision Sciences, Inc.
Product: Fargo Ortho-K Lens
Product code: NUU Lens, Contact, Orthokeratology, Overnight
Reason for recall: Manufactured lenses are not covered by existing FDA approval
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 18,820 lenses
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, Vietnam.
Product codes and lots: All Lots, DI - B22208

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2516-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2515-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-05
Z-2516-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-13	2023-09-05

Product code NUU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)