Device product
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.
Z-0691-2018
Product summary
- Event
- Event 79073
- Status
- Terminated
- Classification
- Class III
- Quantity
- 120
- Official record key
device-enforcement:Z-0691-2018
Official wording
Reason: 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.
Code information: Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978,
Distribution pattern: USA Distribution
Derived failure modes
-
Labeling or packaging
labeling error