FDA-Device2013-01-09Class II
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Cooper Vision Caribbean Corp.
Hazard
The lenses exceeded the acceptance limit for silicone oil residual.
Sold states
US Nationwide, including Puerto Rico, and Canada.
Affected count
246
Manufactured in
#500 Road 584, Amuelas Industrial Park, Juana Diaz, PR, United States
Products
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0631-2013Don't want to check this manually?
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