U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm identified a labeling error affecting made-to-order
(mto) biofinity xr toric blister labels. the primary blister reads biofinity multifocal toric in error, and should read biofinity xr toric. the outer carton correctly reads biofinity xr toric.
조치
Notifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273.
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK || Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.