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Bausch & Lomb Inc Irb recalls BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lense
Recalled November 11, 2015 · FDA recall Z-0206-2016 · 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. · FDA Class II
Units
Domestic: 99,260 lenses; Foreign: 84,660 lenses
Sold at
Distributed US (nationwide), Canada, Japan and Thailand.
Description
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.
Product
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.
Manufacturer(s)
Bausch & Lomb Inc Irb
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →