Home / Recalls / PARAGON VISION SCIENCES, Inc / Z-2516-2023

Z-2516-2023 Class II Ongoing

Recalled by PARAGON VISION SCIENCES, Inc — Gilbert, AZ

Recall Details

Product Type: Devices
Report Date: September 13, 2023
Initiation Date: June 26, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18,820 lenses

Product Description

Fargo Ortho-K Lens

Reason for Recall

Manufactured lenses are not covered by existing FDA approval

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.

Code Information

All Lots, DI - B22208