Device product
Fargo Ortho-K Lens
Z-2516-2023
Product summary
- Event
- Event 92719
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,820 lenses
- Official record key
device-enforcement:Z-2516-2023
Official wording
Reason: Manufactured lenses are not covered by existing FDA approval
Code information: All Lots, DI - B22208
Distribution pattern: 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.
Derived failure modes
-
Unknown
Manufactured lenses are not covered by existing FDA approval