Manufactured lenses are not covered by existing FDA approval
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. Quantity: 18,820 lenses Lot/code info: All Lots, DI - B22208
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.