Recall Z-0691-2018
CooperVision Inc. · initiated September 1, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0691-2018
- Initiated
- September 1, 2017
- Terminated
- July 30, 2018
- Product code
- LPM – Lenses, Soft Contact, Extended Wear
- Quantity
- 120
- Distribution
- USA Distribution
- Recalling firm
- CooperVision Inc., W Henrietta, NY