PARAGON VISION SCIENCES, Inc recalls ISee Ortho-K Lens

Recall date

June 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2515-2023

FDA classification

Class II

Brand / firm

PARAGON VISION SCIENCES, Inc

Sold / distributed

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…

Why it was recalled

Manufactured lenses are not covered by existing FDA approval

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ISee Ortho-K Lens