Recall Z-2516-2023 ยท NUU Lens, Contact, Orthokeratology, Overnight
PARAGON VISION SCIENCES, Inc
Fargo Ortho-K Lens
| Date | Sep 5, 2023 (initiated Jun 26, 2023) |
| Status | Open, Classified |
| Reason | Manufactured lenses are not covered by existing FDA approval |
| 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 Me |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.