Class 2 Device Recall Fargo OrthoK Lens

• Date Initiated by Firm: June 26, 2023
• Date Posted: September 05, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2516-2023
• Recall Event ID: 92719
• PMA Number: P870024S043
• Product Classification: Lens, contact, orthokeratology, overnight - Product Code NUU
• Product: Fargo Ortho-K Lens
• Code Information: All Lots, DI - B22208
• Recalling Firm/ Manufacturer: PARAGON VISION SCIENCES, Inc; 2120 W Guadalupe Rd Ste 112; Gilbert AZ 85233-2810
• For Additional Information Contact: Cooper Vision Customer Service; 800-889-0379
• Manufacturer Reason for Recall: Manufactured lenses are not covered by existing FDA approval
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NUU and Original Applicant = CooperVision, Inc.