Biofinity XR Toric contact lenses 8 — Class III medical device recall Z-0691-2018
Terminated recall by CooperVision Inc., reported 2018-03-07. The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The prim
| Recall number | Z-0691-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperVision Inc., W Henrietta, NY, United States |
| Recall initiated | 2017-09-01 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2018-07-30 |
| Quantity | 120 |
| Reason classes | labeling |
| Lot numbers | R12483347, R12496166, R12496182, R12496191, R12496192, R12496196, R12497769, R12498168, R12501147, R12502974, R12508370, R12508969, R12514162, R12518889, R12518890, R12518978, R12518980, R12519016 |
| Expiration dates | 2017-07-11 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0691-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.