FDA-Device2014-11-05Class III
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
Cooper Vision Caribbean Corp.
Hazard
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Sold states
Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.
Affected count
13639 lenses/246 product lots
Manufactured in
#500 Road 584, Amuelas Industrial Park, Juana Diaz, PR, United States
Products
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2015Don't want to check this manually?
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