FDA recall Z-2516-2023

Product

Fargo Ortho-K Lens

Reason for recall

Manufactured lenses are not covered by existing FDA approval

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-06-26

Report date

2023-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gilbert, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2023