Reported Mar 7, 2018 · Terminated
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are…
CooperVision Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperVision Inc. · 180 Thruway Park Dr · W Henrietta, NY · 14586-9798
Is this the product you have?
- 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.
- Lot codes and dates
- Exp. date 2017-07-11
- Lots
R12497769R12519016R12508969R12496191R12514162R12518889R12483347R12518980R12496182R12496192R12498168R12502974R12496166R12496196R12501147R12508370R12518890R12518978
- Amount recalled
- 120
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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