Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydr...
FDA Device Recall #Z-0691-2018 — Class III — September 1, 2017
Recall Summary
| Recall Number | Z-0691-2018 |
| Classification | Class III — Low risk |
| Date Initiated | September 1, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperVision Inc. |
| Location | W Henrietta, NY |
| Product Type | Devices |
| Quantity | 120 |
Product Description
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.
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.
Distribution Pattern
USA Distribution
Lot / 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,
Other Recalls from CooperVision Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2146-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... | May 19, 2021 |
| Z-2150-2021 | Class II | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... | May 19, 2021 |
| Z-2148-2021 | Class II | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 ... | May 19, 2021 |
| Z-2144-2021 | Class II | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/0... | May 19, 2021 |
| Z-2153-2021 | Class II | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 ... | May 19, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.