FDA-Device2023-09-13Class II
ISee Ortho-K Lens
PARAGON VISION SCIENCES, Inc
Hazard
Manufactured lenses are not covered by existing FDA approval
Sold states
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.
Affected count
83,542 lenses
Manufactured in
2120 W Guadalupe Rd Ste 112, N/A, Gilbert, AZ, United States
Products
ISee Ortho-K Lens
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2023Don't want to check this manually?
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