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Cooper Vision Caribbean Corp. recalls ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copoly
Recalled November 5, 2014 · FDA recall Z-0134-2015 · Cooper Vision Caribbean
Hazard
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. · FDA Class III
Units
13639 lenses/246 product lots
Sold at
Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.
Description
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Product
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.
Manufacturer(s)
Cooper Vision Caribbean Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →