BIOFINITY XR TORIC Lenses — Class II medical device recall Z-3310-2024
Ongoing recall by CooperVision, Inc., reported 2024-10-09, distributed nationwide. Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual a
| Recall number | Z-3310-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperVision, Inc., West Henrietta, NY, United States |
| Recall initiated | 2024-08-29 |
| Classified | 2024-09-30 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 607 lenses |
| Lot numbers | RD0122830, RD0122954, RD0122963, RD0123016, RD0123055, RD0123135, RD0123147, RD0123159, RD0123160, RD0123172, RD0123187, RD0123193, RD0123197, RD0123206, RD0123212, RD0123250, RD0123254, RD0123261, RD0123265, RD0123268, RD0123284, RD0123294, RD0123307, RD0123321, RD0123323, RD0123327, RD0123346, RD0123347, RD0123379, RD0123382, RD0123404, RD0123405, RD0123408, RD0123419, RD0123428, RD0123433, RD0123442, RD0123488, RD0123492, RD0123499 and 94 more |
Product
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reason for recall
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
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-3310-2024. 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.