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PARAGON VISION SCIENCES, Inc recalls Fargo Ortho-K Lens
Recalled September 13, 2023 · FDA recall Z-2516-2023 · PARAGON VISION SCIENCES
Hazard
Manufactured lenses are not covered by existing FDA approval · FDA Class II
Units
18,820 lenses
Sold at
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.
Description
Manufactured lenses are not covered by existing FDA approval
Product
Fargo Ortho-K Lens
Manufacturer(s)
PARAGON VISION SCIENCES, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →