FDA-Device2015-11-11Class II
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
Bausch & Lomb Inc Irb
Hazard
The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
Sold states
Distributed US (nationwide), Canada, Japan and Thailand.
Affected count
Domestic: 99,260 lenses; Foreign: 84,660 lenses
Manufactured in
1400 Goodman St N, N/A, Rochester, NY, United States
Products
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2016Don't want to check this manually?
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