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Recall Observatory FDA recall evidence

Device product

Fargo Ortho-K Lens

Z-2516-2023

June 26, 2023

Class II

Product summary

Firm
PARAGON VISION SCIENCES, Inc
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

    reason.no_named_rule · v1.0.0

    Manufactured lenses are not covered by existing FDA approval